About this opportunity
Grove Technical Resources lists this Principal Quality Engineer - Medical Device - W2 opportunity in waukegan, Illinois. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
Worksite address
waukegan, IL, 60087, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.