Quality Engineer II
On-siteNanakramguda, State of Telangāna, Republic of India
Job Summary
Develop comprehensive product risk management files including risk management plans, hazard analyses, and DFMEAs adhering to ISO 14971 standards. Conduct thorough reviews of new and modified product design documentation to assess manufacturability, serviceability, and compliance with product requirements. Gather and analyze data related to device performance and safety to independently develop periodic safety update plans and reports for regulatory submission. Independently review Design History Files and Technical Files to ensure alignment with FDA Quality System Regulations, EU MDR, and ISO 13485 standards. Collaborate with cross-functional teams to facilitate resolution of product complaints and safety issues while delivering presentations on project status to the QA organization.
Required Qualifications
- Bachelor's degree in engineering, Science, or Technical Discipline
- 5-8 years of quality systems experience
- Good communication skills, both oral and written
- Comfortable working with international and multi-cultural departments and groups in different time zones
- Familiar with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards
- Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
- Understanding of post-market surveillance processes and adverse event reporting
- Knowledge of risk management principles and hazard analysis in the context of medical devices
- Capability to conduct thorough reviews of new and modified product design documentation
- Subject matter expert in risk management for designated medical device products or platforms
- Hands on experience in signal evaluation trending and reports
- Previous experience working in a cross-functional team environment
- Familiar with statistical software tools (Minitab)
- Quality certification – ASQ CQE, CQA and/or CSQE
- Working knowledge of Standard, Guidance, and Regulations
- Lean Six Sigma Yellow belt /Green Belt
Desired Qualifications
- Experience in post market quality
- Good interpersonal skills
- Previous experience working with global team (Aerospace, Defense, Med device, automobile preferably)
- Exposure to FDA Quality System Regulation & ISO 13485 standard
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.