Quality Engineer - Spark Life Solutions Inc
Boston, MA 02110
About the Job
Roles & Responsibilities:
- Establish and maintain master validation program, including site and individual products and process master validations
- Create/Review/Support validation protocols and reports to support process and reliability improvements
- Support complaint handling program, including complaint analysis, investigation, and follow up
- Lead and/or support reliability and process improvements projects from quality perspective
- Establish and maintain process controls/SPC for specific production processes
- Support corrective and preventive action (CAPA) program
- 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 of 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 releae 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 team 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, develop, 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.
Education & Experience:
- 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, ISO10993,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.
Source : Spark Life Solutions Inc
