Sr Quality Engineer
Sr Quality Engineer
Posted on :
02-09-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Responsibilities:
- Lead Quality Engineering activities in new product development (design control risk management verification/validation).
- Develop and maintain the Risk Management File (RMF) and Design History File (DHF).
- Provide statistical guidance for design verification validation and test method validation.
- Act as SME for software quality including code reviews software security and BOM management.
- Support product design transfer production and remediation of anomalies (bugs cybersecurity vulnerabilities).
- Drive Quality System updates CAPA resolution and quality support for released products.
- B.S./M.S. in Biomedical Software Electrical Engineering or related field.
- 8 years of progressive Quality Engineering experience in the medical device industry (hardware and software).
- Strong knowledge of FDA CFR 820 ISO 13485 ISO 14971 IEC 60601 IEC 62304 IEC 62366.
- Proven expertise in design development verification validation and testing of medical devices.
- Skilled in statistical tools quality engineering methods and data analysis.
- Excellent communication problem-solving and project management skills.
- ASQ CQE Six Sigma Black/Green Belt experience with SaMD AI/ML AAMI TIR45 and cloud-based infrastructures.
Employment Type
Full-time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
