Quality Assurance Specialist
24 hours ago
At Spark Life Solutions, Inc., we are seeking a highly skilled Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality engineering and a proven track record of implementing process improvements and ensuring compliance with regulatory requirements.
Key Responsibilities:
- Establish and maintain master validation programs, including site and individual product validations.
- Create, review, and support validation protocols and reports to support process and reliability improvements.
- Support complaint handling programs, including complaint analysis, investigation, and follow-up.
- Lead and/or support reliability and process improvements projects from a quality perspective.
- Establish and maintain process controls/SPC for specific production processes.
- Support corrective and preventive action (CAPA) programs.
- Review and modify product designs and process documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product and quality system requirements.
- Review and provide feedback on protocols and reports, test vendor qualification, and testing management.
- Assist with the development and maintenance of product risk management files.
- Assist with design verification testing and test method assessment and validation activities.
- Recommend requirements for first article inspection, incoming and in-process inspections, and lot release testing, including sampling strategy and test methods.
- Participate in failure investigations to analyze internal system or process failures and to implement corrective and preventive action.
- Participate in component and service new supplier evaluation. Works with suppliers to ensure appropriate quality controls are implemented.
- Audit Design History Files and works with cross-functional teams to resolve documentation issues.
- Identify and implement good quality engineering practices, including statistical methods and root cause analysis tools.
- Participate in supplier material-related processes, which include coordination of MRB activities to ensure the timely assessment of potential non-conforming products.
- Support continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops, and implements effective and compliant solutions for product or process corrections, remediation action plans, and for CAPA.
- Demonstrate the ability to implement ISO 14971, including risk evaluation techniques.
Requirements:
- Bachelor's degree preferably in an engineering or scientific discipline from a four-year college or university.
- 5+ years related experience and/or training; or equivalent combination of education and experience.
- Medical Device or Class II device experience preferred.
- A working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971, ISO 10993, ISO 11135, and the EU Medical Device Directive is a plus.
- Familiarity with test methods and standards for the design, verification, and validation of medical device products is required.
- Experience with PPAP, PMEA.
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