Quality Engineer
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Job Location:
Morrisville, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Quality Engineer
Were seeking a Quality Engineer II to join the team in Morrisville NC. This role requires strong experience in quality systems audits CAPAs and root cause analysis with a background in GMP-regulated industries.
12 months contract- contract to hire
Pay rate: $44h
Additional Information
This role will not accept visa sponsorship (including H-1B and other visas).
Position is available only as W2 contract-to-hire.
C2C arrangements will not be considered.
Key Responsibilities
Lead and support quality events complaints CAPAs SCARs and audits (internal and supplier).
Manage and maintain systems for complaints CAPAs calibration validations and environmental monitoring.
Develop review and approve quality methods procedures and reports.
Support manufacturing operations with process controls and validations.
Conduct root cause investigations risk assessments and statistical quality analysis.
Collaborate across departments to drive compliance with regulatory standards and continuous improvement initiatives (ABS Lean).
Provide training technical writing and quality-related guidance at all organizational levels.
Qualifications
Bachelors degree in a life/natural science field (preferred in medical device biotech or pharma).
35 years of experience in Quality Engineering/Assurance or similar role.
Proven experience with audits CAPAs and QMS/ERP systems.
GMP knowledge and ISO 9001:2015 familiarity required.
Strong problem-solving technical writing and organizational skills.
CQE/CQA certification preferred.
Key Skills
- APQP
- Quality Assurance
- Six Sigma
- ISO 9001
- PPAP
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
Niche executive search firm with 30+ years specializing in executive search and staffing in Medical Device, Biotech, Pharma, and Diagnostics. Jacobs Management Group is a WBENC certified retained and contingent search firm with 30+ years of industry success and a national network.
