Job Summary:

• Implements incoming, molding part audit and drafts audit report.
• Implements FG shipment inspection and drafts FG final inspection report.
• Visit to sub-suppliers and perform audit 
• Performs PQP audit to ensure manufacturing process follow Waterpik established quality processes and procedures.
• Drafts monthly quality statistical report, objective and planning.
• Monitors and verifies supplier corrective actions.
• Assists investigation of root causes of product-related customer complaints.
• Check and verify of new or modified assembly process, inspection/testing equipment, gage, fixture and method.
• Monitors and witnesses material scrap, disposition of nonconforming materials and products.
• Monitors ECO (Engineering Change Order) implementation.

Skills on Resume:

• Quality Auditor (Hard Skills)
• Supplier Auditor (Hard Skills)
• Quality Analyst (Hard Skills)
• Process Engineer (Hard Skills)
• Customer Support (Soft Skills)
• Process Auditor (Hard Skills)
• Compliance Coordinator (Hard Skills)
• Change Analyst (Hard Skills)

Job Summary:

• Work closely with Product Owner and developers to help design, build and test new features
• Convert user stories into test cases
• Executing test cases and reviewing results
• Actively participate in improving QA processes, procedures, and implementing best practices
• Support Quality Management System.
• Support the implementation of continuous improvement and harmonization of the quality system across all sites.
• Effectively collaborate cross-functionally to facilitate the completion of documents.
• Maintain Quality Management Systems for functional area including Design Controls, Software Development, Risk Management, Corrective and Preventative Action (CAPA) system and Non- Conforming Material Reports.
• Support root cause analysis and implementation of correction, corrective and preventative actions
• Be responsible for developing, measuring, and monitoring key performance indicators.

Skills on Resume:

• QA Specialist (Hard Skills)
• Test Engineer (Hard Skills)
• QA Analyst (Hard Skills)
• Quality Improvement Coordinator (Soft Skills)
• Quality Systems Support (Hard Skills)
• Quality System Integrator (Hard Skills)
• Document Control Specialist (Soft Skills)
• Performance Analyst (Hard Skills)

Job Summary:

• Actively collaborate with developers, QA lead, and Product Manager to shape the product and deliver product releases
• Provide feedback to the team on product quality, call out risks/issues, and balance quality with time bound delivery with a release perspective
• Maintain and write automated test suites
• Understand the product domain
• Focus on supporting the quality management system including investigations, CAPA’s, procedure development and maintenance, and quality metrics
• Develop Quality Systems and establish procedures in compliance to FDA regulations, ISO requirements, and other applicable global regulations and standards
• Direct and support Engineering, Inspection, Calibration, Internal Auditing, CAPA, Quality Engineering, and Document Control 
• Represent Quality for projects that may include product, process, or Quality System improvements
• May own and manage CAPA and/or Investigation system(s) and act as system administrator for the associated software
• Support Quality Systems (e.g. Procedure Development/Maintenance, Corrective and Preventive Actions, Investigations, etc.) and domestic/international regulatory compliance activities
• Work closely with Quality Management and other departments in developing and executing company strategies

Skills on Resume:

• Collaboration Specialist (Soft Skills)
• Release Manager (Soft Skills)
• Automation Engineer (Hard Skills)
• Domain Expert (Soft Skills)
• QA Analyst (Hard Skills)
• Compliance Specialist (Hard Skills)
• QA Coordinator (Hard Skills)
• Strategy Facilitator (Soft Skills)

Job Summary:

• Perform analysis on assembly, process, test, mechanical, electrical, and electromechanical quality records to validate data accuracy, acceptability and completeness.
• Develop and coordinate Quality metrics reports and presentation packages.
• Maintain and support Quality records.
• Ongoing documentation of all discrepancies and engagement with engineering and manufacturing to disposition non-conformances.
• Develop and provide recommendations to resolve discrepancies and corrective action for recurring nonconformance's.
• Ensure that corrective measures meet acceptable quality standards.
• Accomplishes related special projects 
• Conducts all activities in a manner that is at all times fair, moral, ethical and legal.
• Conducts all business activities in a manner consistent with the guiding principles and business practices contained in the Ethics code.
• Verify effectiveness of actions as periodically required in the identification and resolution of issues.

Skills on Resume:

• Data Analyst (Hard Skills)
• Quality Metrics Developer (Hard Skills)
• Records Manager (Hard Skills)
• Discrepancy Analyst (Hard Skills)
• Solutions Developer (Hard Skills)
• Quality Assurance Specialist (Hard Skills)
• Project Coordinator (Soft Skills)
• Ethics Compliance Officer (Soft Skills)

Job Summary:

• Provides interpretation of complex requirements.
• Develops quality metrics, design and production certification plans for large programs to ensure compliance with contractual, company and regulatory requirements.
• Lead or support resolution of process variation, chronic defects, or escapes (Continuous Improvement)
• Leads various reviews to ensure quality attributes are incorporated into product designs.
• Performs advanced analysis to ensure specified processes capability levels are achieved.
• Provide leadership and project management support of key quality initiatives
• Data analysis to Identify trends, failure modes, chronic failures, process variation and process capability
• Support development and implementation of new technology or manufacturing processes
• Coordinate with other engineering functions, manufacturing and support functions to ensure compliance to regulators and contractual requirements
• Attend daily stand-up meetings with the development team to ensure close working relationships with them and to understand the testing load that is upcoming.

Skills on Resume:

• Requirements Analyst (Hard Skills)
• Quality Planner (Hard Skills)
• Process Improvement Lead (Hard Skills)
• Design Review Lead (Hard Skills)
• Process Analyst (Hard Skills)
• Quality Project Manager (Soft Skills)
• Data Analyst (Hard Skills)
• Engineering Coordinator (Soft Skills)

Job Summary:

• Perform non-conformance investigations to determine root case. 
• Assign and ensure completion of corrective and preventive actions. 
• Complete investigations in a timely manner to ensure customer service levels are maintained. 
• Coordinate the reporting and provide trend analysis for non-conformance incidences.
• Determines equipment qualification, process validation, and product line design/modifications requirements. 
• Works with Manufacturing on installation and maintenance of inspection
• Testing procedures for raw materials, packaging materials, components and finished products. 
• Supports design transfer activities.
• Assists in development and maintenance of Risk Management documentation.
• Works with Manufacturing to provide feedback to production personnel regarding accuracy of assembly procedures.

Skills on Resume:

• Non-Conformance Analyst (Hard Skills)
• CAPA Manager (Hard Skills)
• Investigation Analyst (Hard Skills)
• Trend Analyst (Hard Skills)
• Validation Expert (Hard Skills)
• Inspection Coordinator (Hard Skills)
• Design Support (Hard Skills)
• Risk Assistant (Hard Skills)

Job Summary:

• Possesses and applies fundamental and increasing knowledge of Quality
• Application within RDIL, to the completion of routine assignments.
• Works in compliance with established procedures and/or protocols.
• Identifies and resolves readily identifiable, clearly defined problems.
• Demonstrates skill in data analysis techniques by resolving missing/incomplete information in routine assignments.
• Administration and Organization of documentation relating 
• Preparation and implementation of MDR/IVDR including recognizing where escalation points  
• Occasional hot-fixes and emergency tests are required if a bug is found in production environment that affects customer base.
• Develop team members and help train quality technicians
• Perform inspections using an OGP Smartscope, Comparator, Calipers, Micrometers

Skills on Resume:

• Quality Analyst (Hard Skills)
• Compliance Specialist (Hard Skills)
• Problem Solver (Soft Skills)
• Data Analyst (Hard Skills)
• Documentation Coordinator (Hard Skills)
• Regulatory Preparer (Hard Skills)
• Emergency Tester (Hard Skills)
• Inspection Technician (Hard Skills)

Job Summary:

• Participate in small size validation (Equipment) projects
• Participate with risk assessments for new systems and changes to existing systems
• Write simple validation plans, protocols and reports
• Create, own, and manage life cycle of minor deviations, corrective actions and change controls for GMP equipment, facilities and automation systems
• Operate within the relevant quality computer systems (ex. SAP, TrackWise) ensuring implementation in line with quality and timeliness objectives
• Working closely with Engineering, Quality, Process Development, Validation, and Manufacturing to investigate and resolve deviations including leading investigation teams in order to determine root cause, product impact, and appropriates corrective and preventive actions
• Preparing material for internal and external regulatory and customer auditors
• Participate in generating quality system metrics for the EandT department
• Test (manual and automated) completed tickets that have been merged to the master branch of the system.
• Testing includes working with mobile devices, web, and command-line systems to ensure the correctness of the system and its parts.

Skills on Resume:

• Validation Specialist (Hard Skills)
• Risk Assessment Analyst (Hard Skills)
• Protocol Writer (Hard Skills)
• Change Control Manager (Hard Skills)
• Quality Systems Operator (Hard Skills)
• Deviation Investigator (Hard Skills)
• Audit Coordinator (Hard Skills)
• Quality Metrics Analyst (Hard Skills)

Job Summary:

• Improve product quality through issue tracking, analysis, and corrective actions
• Facilitate customer-sensitive quality crisis management, support supplier audits
• Assist with manufacturing and test instruction review
• Perform first article inspection for electronic and mechanical parts
• Lead failure analysis investigations on electrical, mechanical, and software issues
• Develop strong relationships with Omron's world-class factories and quality partners
• Develop quality plans and production control plans for next-generation products
• Assist in managing the QC laboratory
• Develop test methods and inspection procedures and implement process control systems to support the development, qualification, and on-going manufacturing of products
• Support continuous improvement and CAPA projects, and proactively identify and implement best-in-class quality engineering practices.
• Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues

Skills on Resume:

• Quality Analyst (Hard Skills)
• Crisis Facilitator (Soft Skills)
• Inspection Lead (Hard Skills)
• Article Inspector (Hard Skills)
• Failure Analyst (Hard Skills)
• Relationship Manager (Soft Skills)
• Quality Engineer (Hard Skills)
• QC Manager (Hard Skills)

Job Summary:

• Assists in conducting and documenting process and system audits using specific regulations and company procedures as audit standards
• Assist receiving inspection requirements interpretation 
• Participate in the supplier qualification, approval and selection process.
• Team member on various manufacturing related projects including CAPA and NCR
• Supports training activities related to product quality, cost, reliability, and regulatory compliance. 
• Develops strategies to ensure continuous improvement in the ability to design and manufacturing quality products.
• Maintains an up‑to‑date knowledge of the techniques of Quality Assurance/Quality Control and in the company products and process technologies.
• Resolve issues manufacturing engineering and supplier quality impacting product quality.
• Support in house manufacturing and customer complaint issues.
• Work with Tech support team to validate bugs found by them or customers.

Skills on Resume:

• Audit Assistant (Hard Skills)
• Inspection Analyst (Hard Skills)
• Supplier Evaluator (Hard Skills)
• Project Team Member (Soft Skills)
• Training Support Specialist (Soft Skills)
• Strategy Developer (Soft Skills)
• QA/QC Expert (Hard Skills)
• Issue Resolution Specialist (Soft Skills)