• Reviews the content, thoroughness and quality of the work generated through product development and across the full product lifecycle.
• Promotes design and/or selection of equipment to reduce costs and improve quality.
• Conducts project/team meetings as required to resolve issues, determine current status, provide information, and align work.
• Ensures adequate communication between engineers, technicians, and other departments. 
• Maintains open communication with team members to ensure understanding of needs.
• Executes and reviews/approves documentation associated with design assurance engineering activities to include drawings/schematics, validation/capability testing, various new and revised operating procedures, etc. 
• Monitors new projects and interacts with other engineers to determine design criteria.
• Participates in Engineering Change Order approval process. 
• Leading or participating in Change Management Plans.
• Assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
• Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.

Skills: Content Review, Equipment Selection, Project Coordination, Communication Facilitation, Documentation Approval, Design Monitoring, Change Management, Regulatory Compliance.

• Support New Product Development, Sustaining, and cost-saving projects by ensuring compliance of project activities and documentation to internal QMS requirements as well as external regulations and standards (FDA, ISO, EN).
• Drive design assurance into medical devices as the Quality Lead during all stages of design controls projects through support of user needs, product requirements, design specifications, design verification and validation strategies, usability studies, and design reviews.
• Responsible to generate and maintain project risk management file for NPD and sustaining projects. 
• Risk plans, hazard/failure mode effects analysis, risk mitigations and effectiveness checks, and risk management reports using principles from ISO 14971.
• Assist supplier quality, CMO, manufacturing, marketing and other stakeholders to generate risk assessments using Design, Process, Software FMEAs, FTAs, etc. per requirements of ISO 14971.
• Improve customer interfacing of products by direct analysis of impact through risk evaluation and prioritization of use errors per FDA's and IEC 62366 Human Factors and Usability Engineering for Medical Devices.
• Provide expertise in development and implementation of C/R strategy, statistical support, inspection, sampling plans, test methods during Design Verification and Validation using a risk-based approach.
• Assist with annual post market surveillance activities, ensures effective maintenance of the risk management program for commercialized products, and assess the need to implement design and process changes
• Apply technical problem-solving methodologies to identify, adapt to shifting priorities, communicate, and resolve quality issues.
• Assist with internal and external audits that include FDA, ISO and MDSAP.
• Provide assessment to resolve deviations and contribute to root cause investigations using various problem-solving techniques and tools for NCEs, CAPAs, Field Actions, Health Hazard Evaluations, and assesses effectiveness of corrective actions.

Skills: Compliance Assurance, Design Assurance Leadership, Risk Management File Maintenance, Risk Assessment Generation, Usability Improvement, Statistical Support, Post-Market Surveillance, Technical Problem-Solving.

• Provide expert engineering support with regards to all welding and NDT issues received from internal and external stakeholders including reviewing, commenting on and approving all documentation for welding procedures to be used on National Grid construction projects.
• Provide expert engineering support to coordinate and resolve technical issues received provide expert technical input to project to support any Technical Queries/Deviations with respect to welding, NDT or materials.
• Support the development and implementation of the Gas Transmission Capital Delivery Quality Management Systems (QMS) and the subsequent provision of quality assurance, engineering support and Construction Design & Management (CDM) advice through all phases of project delivery.
• Provide independent quality assurance and management of Quality Engineers to ensure the compliant delivery of all Gas Transmission Capital Delivery schemes.
• Support the technical input for commercial activities including contract documents, Works Information, project scopes, tender events and evaluations.
• Participate in internal and external working groups to develop, review and implement National Grid policies and procedures, specifications and industry standards to drive continuous improvement.
• Support the development and implementation of audits and inspections on construction activities to ensure compliance with design assurance processes and quality management procedures.
• Identify best practice and lessons learned and ensure that these are embedded into specifications, design activities and future Gas Transmission Capital Delivery projects.
• Lead or participate in supplier qualification and monitoring and product Factory Acceptance Testing (FATS) to ensure compliance with specifications and procedures.
• Review and authorisation of product certification, records and materials.

Skills: Welding Expertise, Technical Issue Resolution, Quality Management Systems, Quality Assurance Management, Commercial Support, Policy Development, Audit Implementation, Supplier Qualification.

• Manage and coordinate product design control activities across the organization, including those related to in vitro diagnostic product development, in accordance with FDA, QSR, ISO, and IVDR
• Provide guidance for design controls, risk management, product design change, and other product development activities
• Manage design history files and product files for all products, including clinical diagnostic products
• Compile and manage product risk management files to ensure adherence to internal procedures and applicable regulatory requirements
• Drive continuous improvement for processes and practices related to the product development life cycle
• Manage the product design change review board by facilitating meetings and any resulting action items
• Carry out training and communication activities with staff to ensure adequate understanding and competency of product development life cycle requirements
• Ensures adherence and maintains effectiveness of the Quality System
• Collaborate on work efforts and projects in a cross functional environment
• Build and maintain effective cross-functional relationships internal departments such as R&D, Commercial, Laboratory Operations, and Regulatory Affairs
• Demonstrates good, general understanding of the standards and regulatory bodies that regulate industry
• Ensures risk is considered and addressed to promote product safety and efficacy

Skills: Design Control Management, Risk Management Guidance, Design History File Management, Regulatory Compliance, Process Improvement, Change Review Management, Staff Training, Cross-Functional Collaboration.

• Quality lead with the goal to be closely engaged in R&D projects on new product development
• Partner with Risk Manager and Complaint Manager to ensure compliance in all products
• Proactively provide guidance to maintain and improve compliance of development projects in coordination with global and local processes
• Represent QA function within the core teams in charge of the development process
• Ensure conformity of the design process with applicable regulation
• Review and approve design and development documentation related to the projects he/she’s in charge
• Develop and execute validation plans and protocols
• Responsible for DHF completeness and maintenance
• Generate and maintain the risk management files
• Drive risk assessments and support project during risk management activities

Skills: Quality Leadership, Compliance Partnership, Project Guidance, QA Representation, Design Process Conformity, Documentation Review, Validation Plan Development, Risk Management.

• Provision of on-going regulatory compliance, risk management, design control, quality systems and overall design assurance expertise and leadership to the EMEA Packaging & Labelling Design & Development Centre of Excellence team on an on-going basis.
• Provision of regulatory and quality systems leadership to the team as it transitions to Packaging & Labelling Design Ownership (Design Authority).
• Liaison with corporate, local and EMEA sites quality systems and regulatory affairs personnel to ensure team’s compliance and to drive alignment and harmonization.
• Monitoring of the release and updates to regulatory & quality standards, regulations and policies, execution of gap analysis, communication of changes to the team and driving compliance.
• Driving the implementation, maintenance and update of procedures that ensure packaging and labelling design controls are met.
• Creating and maintaining risk management documentation.
• Providing independent quality review for design reviews, project design plans, risk management, design validation protocols & reports for both design and development projects.
• Support the team in design & development activities, carried out on behalf of other EMEA sites.
• Support the establishment of a Packaging Testing Laboratory in the Galway site.
• Support the integration of the team into the Galway site QMS.
• Provide direction for documentation Control, CMS (Change Management System) and CAPA processes.
• Manage communications with regulatory bodies such as BSI.
• Provide leadership in the preparation for and during audits. 
• Take the lead and front the team’s participation in audits.

Skills: Regulatory Compliance, Quality Systems Leadership, Cross-Site Liaison, Standards Monitoring, Design Control Implementation, Risk Management Documentation, Independent Quality Review, Audit Preparation.

• Ensure a compliant execution of new Product Development projects and Life Cycle Management activities including the review and approval of design control and change control relevant documents, in accordance with internal procedures and applicable regulatory requirements
• Act as a consultant for the development teams / project team members to find pragmatic ways to achieve appropriate and compliant documentation of activities
• Participate in change control activities (review and approval of change requests), in design review meetings and review of respective documentation
• Support and review documents related to product, design and process risk management activities (and provide guidance)
• Honing subject matter expertise in Design Controls (21 CFR 820.30), Risk Management (ISO 14971), Usability engineering (IEC 62366-1), product-specific standards (e.g., ISO 4049, ISO 10650), and industry-specific regulations, standards, and guidance documents.
• Building relationships and working directly with Research and Development, Product Development, Clinical Affairs, Quality Assurance, Regulatory Affairs, among others, to make sure user and patient needs are met and that quality and regulatory considerations are covered in the design and evaluation of products.
• Training and coaching project team members on best practices for design controls, risk management, and product-specific requirements arising from regulations, standards, and industry guidance documents.
• Communicating with subject matter experts to create design verification and design validation plans.
• Participating in cross-functional activities such as creating and reviewing design inputs, conducting risk assessments, developing test strategies, and guiding test protocol and method development.
• Improving systems and tools used in the development of products.
• Building and supporting Risk Management and Usability Engineering files.

Skills: Product Compliance, Documentation Consulting, Change Control Management, Risk Management Support, Design Control Expertise, Cross-Functional Collaboration, Training & Coaching, Systems Improvement.

• Execute and Support Design Verification activities related to Design Assurance (Complete QA/DA documentation, review the verification process and its outputs)
• Execute and Support Design activities related to Design Assurance as a part of the Product Development Process (Documentation, reviews)
• Manage documentation in the Document Control System
• Elevate compliance issues 
• Prepare the site for internal/External audits
• Assist regulatory compliance staff during internal and external compliance audits by gathering information
• Assist the business in identifying corrective actions to address regulatory deficiencies.
• Support Equipment Life Cycle Management
• Train the team in QA/DA related topics

Skills: Design Verification, Documentation Management, Compliance Elevation, Audit Preparation, Regulatory Assistance, Corrective Action Identification, Equipment Management, QA Training.

• Provide guidance and leadership to organization in the development and maintenance of products.
• Develop and manage quality related deliverables during product development such as advanced quality plans, standards based testing, etc.
• Interact with subcontractors for contract design activities where applicable.
• Work with R&D to develop and manage product risk files including development of product risk plans, risk analyses, failure modes effects analysis (design, product, application, process), etc.
• Work with R&D to evaluate and catalog applicable technical standards that drive device performance, work with test agencies to establish test requirements, manage agency testing.
• Develop and document test protocols and summary reports.
• Work with R&D to develop product specifications including performance, human factors, quality and regulatory related specifications assuring that specifications are able to be verified and/or validated.
• Develop and maintain usability files for products including, as applicable, development of usability protocols, tests and summary reports.
• Drive the advanced quality planning process including development of written quality plans for products: identification of key component attributes for inspection and/or process control, identification of key suppliers requiring supplier qualifications and audits, support the development of device history records and device master records, and support the overall transfer of products from R&D into manufacturing.

Skills: Product Leadership, Quality Planning, Risk Management, Standards Evaluation, Test Development, Specification Management, Usability Maintenance, Supplier Audits.

• Perform supplier audits where applicable and document and maintain supplier files.
• Responsible to ensure that design control processes are implemented and for constructing and/or auditing the Design History File for designated products.
• Review and approve product development documentation as the quality representative including design control deliverables, components specifications, bills of materials, and design changes.
• Attend design reviews and assist as the quality representative. 
• Own and resolve assigned actions.
• Assist R&D in change management.
• Assist in the investigation, documentation and review of product complaints.
• Perform trends analysis of quality system data for management review.
• Assist in third party audits as applicable.

Skills: Supplier Audits, Design Control Implementation, Design History File Management, Product Development Documentation Review, Design Review Participation, Change Management Assistance, Product Complaint Investigation, Quality System Data Analysis.

• Experience working in a regulated medical device or pharmaceutical company.
• Excellent planning and coordination skills.
• Excellent verbal and written communication skills.
• Excellent attention to detail skills.
• Ability to work within a team environment to achieve agreed company goals.
• Ability to communicate quality / regulatory concepts effectively.
• Excellent understanding of ISO 13485 and FDA QS regulations.
• Understanding of Quality Systems.
• Understanding of Design Control Process.
• Proficiency in the use of desktop software applications such as MS office, Word, Excel, PowerPoint.

Qualifications: BA in Industrial Design with 5 years of Experience.

• Demonstrated knowledge of FDA Quality System Regulation, ISO 13485 Quality Management System and ISO 14971 Risk Management for Medical Devices
• Significant experience working with new product design/development projects or sustaining engineering projects
• Experience in complying with Design Controls and mentoring other organizations regarding Design Control requirements and expectations
• Strong organizational skills and ability to prioritize workflow to meet established time frames and schedules
• Able to constructively collaborate with cross-functional teams
• Demonstrates working knowledge of design for quality tasks, SW functional testing, SW Stress and performance testing within cloud network environments
• Knowledge of GMP, QSR, ISO 13485, ISO 14971, and medical device regulatory requirements
• Experience with Microsoft Office, data management, and documentation equipment/software
• Class II or III medical device experience required structural heart experience 
• Demonstrate knowledge and working practical knowledge of medical device product development including Design Verification & Validation, Risk Management and Statistical Methods, RoHS and REACH Directives

Qualifications: BS in Mechanical Engineering with 2 years of Experience.

• Experience in the medical device industry or equivalent regulated industry (preferably in product development, quality management, risk management, or manufacturing of medical devices).
• Basic understanding and knowledge of standards and regulation including but not limited to: ISO 13485 - Medical devices -- Quality management systems, ISO 14971 - Medical devices -- Application of risk management to medical devices
• Knowledge of 21 CFR 820 - FDA Quality System Regulation, MDR - Medical Device Regulation 2017/745.
• Able to act consequent and efficient, compliant and pragmatic. 
• Strong in discussion with other stakeholders and withstand the tendency to skip necessary steps or do them insufficiently.
• Advanced Statistical methods and problem solving tools
• Familiarity with ISO9001 and internal audit techniques
• Effective verbal and written communication skills
• Detailed and numbers oriented
• Working knowledge, skill, and problem solving ability on personal computer based systems
• Knowledge and experience with spreadsheet and statistical software programs

Qualifications: BA in Quality Assurance with 7 years of Experience.

• Experience in design engineering, quality engineering, or systems engineering for medical products
• Experience in a leadership role
• Ability to lead strategic quality initiatives, ASQ certification
• Effective organization and prioritization skills
• Effective interpersonal skills
• Proven ability to complete projects in a timely manner
• Ability to support a 24/7 global business operation
• Demonstrate discretion, confidentiality, independent judgment and professionalism when representing the company
• Knowledge of IEC 62366, QSR: FDA 21 CFR 820 and ISO 13485/ 14971/ 10017/ 10993 requirements and knowledge of international Standards: ISO 9000,

Qualifications: BS in Biomedical Engineering with 4 years of Experience.

• ASQ Certification(s) and exposure to Six Sigma techniques
• Knowledge of Design Validation and Design Verification tools and techniques
• Excellent verbal communication and technical writing skills
• Ability to interface with multiple groups in the organization 
• Knowledge of risk management tools and techniques. FMEAs, FTAs, ISO 14971 risk management standard
• Dynamic team player and can work effectively and proactively on cross-functional teams.
• Knowledge of anatomical use conditions (anatomy, physiology etc.), system requirements development, design control, application of ISO standards for medical devices.
• Good communicator and fluent in English, both in writing and speaking
• High level of enthusiasm and motivation, and the ability to take input from others are desirable.
• Understanding of mechanical-electrical medical systems, products, and therapies.

Qualifications: BA in Engineering with 3 years of Experience.

• Medical Device experience
• Software proficiency: Microsoft Word, Excel, PowerPoint, Project, Solidworks, Minitab
• Manufacturing process knowledge including: Lean Manufacturing, Packaging, Labeling and Clean room and sterilization processes
• Experience with small to large semi-automated equipment implementation including: Working with outside equipment manufacturers for quotes, Design inputs/outputs and Validations (FAT, SAT, IQ, OQ, PQ)
• Materials selection knowledge including physical properties and biocompatibility
• Good understanding and working knowledge of FDA medical device regulations, ISO 13485, Health Canada medical device regulations, European medical device regulations, ISO 14971
• Demonstrate strong experience with test method validation, protocol and report writing. 
• Experience with EUMDR remediation
• Experience with Process validation like IQ, OQ, PQ
• Good technical capabilities, communication skills, teamwork abilities and initiative.

Qualifications: BS in Biomedical Engineering with 8 years of Experience.

• Practical knowledge of FDA Quality System Regulations, ISO 13485 and Medical Device Directive.
• Practical knowledge of ISO 14971, and related standards
• General familiarity with industry best practices in development, testing and manufacturing processes.
• Experience in interpreting design schematics and drawings.
• Preferred experience with FDA and European regulated medical devices
• Skilled in statistical methods e.g. ANOVA, SPC, test sample size selection plans, Gauge
• Strong written and oral skills
• Strong organizational and management skills
• Strong problem-solving skills
• Strong attention to detail
• Experienced in the compliance of products to relevant standards ISO 13485

Qualifications: BA in Industrial Design with 7 years of Experience.

• Experience in an Good Manufacturing Practices (GMP) environment required, preferably in medical device industry
• Working knowledge of current industry quality practices under QSRs, ISO-13485 and international regulations
• Experience as a member of a design team 
• Experience in regulated environment required, previous design assurance experience 
• Experience with medical device risk management (ISO 14971) 
• Experience with usability (ISO 62366)
• Excellent interpersonal, verbal and written communication skills
• Certification in a quality discipline preferred, such as CQM, CQA, CQE, etc.
• Strong computer skills (Microsoft Windows and Office programs), familiarity with Oracle 
• The high degree of problem-solving and analytical skills
• Ability to apply statistical tools

Qualifications: BA in Engineering with 5 years of Experience.

• Design Quality Assurance experience in a regulated medical device environment, specifically in a product development support role
• Experience in responsibility for compliance with FDA QSR, MDD/MDR and ISO regulations
• Experience in responsibility for medical device Design Verification and Validation activities
• Experience in and responsibility for product and process risk analysis/FMEA, specification writing, test method development and validation, statistical analysis of quantitative and qualitative data, test report writing and medical device design reviews
• Previous work experience in life science products or medical device fields
• Proficient in computer skills such as MS office programs
• Experience in a Design Assurance/ Quality Engineering capacity.
• Proven ability to work well as part of a team & on own with minimum supervision.
• Proven ability to work well both as part of a team but also able to work on own with minimum supervision.
• Ability to communicate appropriately with different teams.

Qualifications: BS in Mechanical Engineering with 3 years of Experience.

• Experience with Class II/III electro-mechanical medical device field
• In-depth knowledge of Design Controls, Risk Management practices, Corrective and Preventative Actions, and regulatory requirements, such as FDA QSR's, ISO 13485, ISO 14971, I.S EN 62366, & ISO 11135
• Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.), including statistical software tools, such as Minitab
• Experience with supporting medical device compliance testing (e.g. EMC, EMI, IEC)
• Strong working knowledge of Microsoft Word and Excel
• Experience with lasers and optical technologies desired
• Experienced in maintaining and updating control and development procedures
• Strong organizational and time-management skills
• Ability to multi-task and meet high expectations and tight deadlines.

Qualifications: BA in Quality Assurance with 6 years of Experience.