The Senior Quality Engineer will help implement the Quality Management System, developing and implementing Quality Plans for New Product Development, creating Risk Management documentation, and developing processes, sampling plans, test protocols and reports in compliance with relevant FDA QSR and ISO requirements.
Senior Quality Engineer job responsibilities:
- Develop and implement Quality Plans and serve as quality representative for new medical device and IVD product development programs
- Develop, coordinate and maintain product risk management documentation, plans and reports including design and process FMEAs
- Perform quality review of and ensure design verification and validation plans and reports meet relevant FDA and ISO requirements
- Work with external vendors to set-up and manage verification studies as needed including biocompatibility, sterilization, transportation, and packaging
- Develop, write and/or update processes for component, sub-assembly, and product inspection and testing
- Create and maintain Master Process Validation and Verification plans and reports
- Participate in the development and maintenance of device master records
- Ensure design, process and manufacturing monitoring/measurement and data/statistical analysis techniques are appropriate
- Evaluate and approve suppliers, monitor supplier performance, and prepare status reports
- Manage feedback from complaint handling and post market surveillance systems
- Document NCMRs (non-conforming material reports), CAPAs, and complaints as needed
- Create, review and maintain quality system documents and records
- Bachelor's degree in mechanical or biomedical engineering, life sciences or related field
- Minimum of 5 years of Quality experience in a related field; Senior level targeting 5-10 years of experience
- Working knowledge document control, design control, traceability, risk management and supplier control processes
- Excellent analytical, problem-solving and decision-making skills
- High attention to detail, and the ability to work in a fast-paced and team environment.
- Experience working within medical device and/or IVD Quality Management Systems
- Familiarity with US and International regulations including 21 CFR 809 and 820, European Medical Device Directive (MDD), IVDD 98/79/EC, MDD 93/42/EEC, ISO 14971
- Experience in supporting external and internal quality audits and regulatory investigations
Sthree US is acting as an Employment Agency in relation to this vacancy.