Are you passionate about ensuring top-notch quality in medical devices? Do you thrive in a dynamic environment where your expertise makes a difference? We're looking for a skilled Quality Engineer to join our team and contribute to maintaining the highest standards of compliance and excellence.
Responsibilities:
- Conduct PMS research and statistical analysis
- Contribute to design verification/validation and IQ/OQ/PQ activities
- Analyze NCMR trend data in MRB meetings
- Develop risk-based sampling plans and perform reliability analysis
- Implement standards for inspection, testing, and process improvement
- Lead CAPA processes and root cause analyses
- Manage risk management processes and QMS documentation
- Assist in FDA/ISO audits and internal audits
- Oversee quality engineering team and calibrated equipment program
- Provide quality input to product development and lead risk management efforts
Requirements:
- Bachelor's degree in Mechanical or Biomedical Engineering
- Minimum 3 years of relevant experience
- Strong knowledge of 21 CFR 820, ISO 13485, and ISO 14971
- Proficiency in MS Office, Adobe, and CAD
Join us in ensuring top-quality medical devices that meet regulatory standards and exceed customer expectations. Apply now to be part of our dedicated team!
Job Type: Full-time
Pay: $80,000.00 - $100,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Application Question(s):
- Do you have experience leading ISO 13485 audits?
Work Location: In person