What are the responsibilities and job description for the Principal Quality Engineer - Medical Device - W2 position at Grove Technical Resources?
Job Title: Senior / Principal Quality Engineer – FDA Remediation
Job Type: Contract – Initial 6 Months, Potential Extension
Location: Glens Falls, NY | Waukegan / Mundelein / Northfield, IL
Work Arrangement: Hybrid
Job Description:
We are seeking experienced Senior / Principal Quality Engineers to support FDA compliance and remediation programs within a regulated medical device or pharmaceutical manufacturing environment. Candidates must be hands-on, capable of independently executing CAPA activities, remediating quality documentation, and driving compliance actions through closure.
Key Responsibilities:
- Execute CAPA and FDA remediation activities according to established plans.
- Review and remediate Risk Management Files, Design History Files (DHF), and design control documentation.
- Review technical files, test reports, validation protocols, and historical product records.
- Update SOPs, procedures, work instructions, and Quality System documentation.
- Identify documentation gaps and implement corrective actions.
- Collaborate with Quality, Engineering, Manufacturing, and Regulatory teams.
- Track remediation deliverables and meet FDA commitment deadlines.
Required Skills:
- Senior-level Quality Engineering / Quality Systems experience
- CAPA execution and closure
- FDA compliance and remediation
- Medical Device / Pharmaceutical / Regulated Manufacturing
- Quality Management Systems (QMS)
- Technical Documentation Review and Remediation
- Strong Technical Writing and Problem-Solving Skills
Preferred Skills:
- Risk Management Files and Design History Files (DHF)
- Design Controls and FDA Warning Letter Remediation
- Manufacturing Quality and Validation Documentation
- Legacy Medical Device / Product Remediation
- SOP and Quality System Remediation
- Education: Bachelor's degree in Engineering, Science, Quality, or a related technical field.