Principal Quality Engineer - Medical Device - W2 Job at Grove Technical Resources, Waukegan, IL

  • Grove Technical Resources
  • Waukegan, IL

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.

Job Tags

Contract work

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