Medway, MA 02053
- Maintain and comply with the requirements of MDSAP, ISO 13485, GMP, and other applicable regulations.
- Implement and develop quality system documentation that is in compliance with the quality manual and associated Standard Operating Procedures (SOPs).
- Support in developing and execution of Validation Master Plans, Equipment Qualifications, Process Validations, and test method validations for successful transfer from development to manufacturing working in a cross-functional group.
- Ensure that required specifications are implemented for incoming/ in-process/ outgoing quality inspections.
- Support in developing and maintaining the dFMEA/pFMEA/ uFMEA process for finished good medical devices working in a cross-functional group. Support/participate in regulatory agency and customer quality audits.
- Participate in design control activities to ensure that product meet specifications, reliability, and manufacturability.
- Working knowledge of CAPA management to drive to root cause analysis and practical corrective and preventive solutions. Utilize formal problem-solving techniques to resolve product and/or process related issues.
- Participates in Material Review Board activities, including manufacturing facilities ensuring proper trending, closure of issues and dispositions are appropriately justified.
- Write and or assist in development of protocols, technical investigation plans, engineering reports, and related procedures which ensure statistical validity, adequacy, and compliance to regulatory and corporate requirements.
- Review and approve specifications (input/outputs), verification and validation, risk management activities, and Quality Plans.
- Conduct Quality Engineering studies relating to product and process development or corrective actions including: Design of Experiments, Test Method Validations, Gage R&R, Cpk, SPC and process validations.
- Working knowledge of concepts of probability and statistic.
- Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues.
- Establishing inspection standards, plans, frequencies and test methods.
- Support Production on all quality-related activities, including working closely with Engineering and other applicable functions.
- Support of customer complaint handling and investigation.
What your background should look like:
- Minimum 5 years working experience in ISO13485 and 21CFR (QSR) environment
- Be able to write excellent technical documents
- Person need to be able to multi task efficiently
- Exposure to 8D methodology of problem solving or other problem solving techniques such as SPS (Statistical Problem Solving)
Meet Your Recruiter
Jen has more than 20 years of staffing experience, the last 10 years have been assisting some of the best engineers navigate to the next step in their career. Jen is very knowledgeable with the current job market, and prides herself on the ability to listen to both her clients and candidates to best understand what is important to them and create the perfect partnerships.
Fun Fact: Jen loves working within all areas of Engineering and is a proud mother of an Engineering Student!!