Senior QA Engineer

Description

• Analyze quality data to identify trends, investigate root causes of quality issues, and implement corrective and preventative actions.
• Assist with non-conformance investigations as assigned.
• Act as Document Controller as necessary
• Provide technical support to cross-functional teams, including product development, operations, and regulatory affairs.
• Support and participate in the implementation of new product design assurance: including Risk management (per ISO 14971), User, Design, and Process FMEAs, requirements traceability matrices, design verification and validation, etc.
• Mentor and train Quality Engineers and Technicians.
• Promotes teamwork by working collaboratively and closely with others, internally and externally.
• Plan and execute assigned process improvement projects.
• Supports management review process through the development and generation of quality system metrics and generates quarterly data for those metrics.
• Review and approval of controlled documentation
• Conduct other routine QA duties such as issuing and reviewing batch documentation, and incoming and finished goods release.
• Collaborate with suppliers and customers to improve quality and resolve quality issues.
• Manage product non-conformances found during manufacturing through NCR and MRB
• Lead or participate in the design, development, optimization, and validation of test methods and inspection procedures. Guide/author design verification and design validation protocols and reports.
• Lead and participate in internal and external audits, including supplier audits and regulatory inspections.
• Utilize statistical analysis techniques to determine product acceptance and sample size requirements.
• Fully support the Quality Department by building quality into all aspects of the process workflow and by maintaining compliance with all quality requirements (including but not limited to supporting training for processes and maintaining associated documentation).
• Encourage an ‘audit-readiness’ culture.
• Conduct Risk assessments and develop risk management plans to mitigate potential quality and safety issues.
• Oversee and maintain an internal Quality laboratory, including all associated processes/procedures, for manufacturing necessary testing solutions.
• Assist in establishing Quality training modules and activities.
• Management, investigation, and reporting of CAPAs and NCR (including root cause analysis) and Effectiveness Checks) for adherence to organizational or departmental targets.
• Support activities associated with agents of regulatory bodies as necessary to demonstrate quality system compliance. Support Certification/ recertification activities for US, European and other markets. Assist with drafting of documentation to support regulatory submission activities and review content for compliance with QSR regulations.
• Overseeing Supplier Management and ensuring supplier evaluations and re-evaluations are completed as necessary.
• Develop and maintain quality systems to ensure compliance with applicable regulations and standards, including FDA, ISO, and CE.
• Support DMR and DHF compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained. Support design and process changes for commercial products.
• Manage the other QC elements related to operation such as Equipment Control, Calibration, and QC inspection lab.

Requirements

• Completes work with a high degree of integrity and strong work-ethic.
• Understanding of root cause analysis
• Strong familiarity with Good Manufacturing Practices and Quality Systems Regulation, Good Laboratory Practice (ISO13485, 21CFR820, and ISO15189 preferred)
• Minimum of 5 years of experience in a highly regulated industry (Medical Devices preferred)
• Experience working with UL
• Demonstrated excellent analytical methods.
• Strong, methodical organizational skills and ability to prioritize.
• Ability to multi-task within a small, dynamic team
• Highly detail oriented with disciplined and effective time management, scheduling, and organizational skills.
• High-level technical writing skills and documentation experience including protocol design, authorship, execution, and reporting; use of root cause analysis techniques.
• Bachelor’s Degree in science or Engineering (preferred)
• Ability to communicate requirements and implement strategies across teams and Departments.
• Experience with Risk Management Files
• Demonstrated excellent problem-solving skills.
• Exceptional attention to detail

Benefits

• Pay Rate: $115K - $120K Base USD Yearly

Training + Development

Interview process

Visa Sponsorship

Security clearance