
Apply Now: Manufacturing Engineer
2 weeks ago
We're looking for a Manufacturing Engineer with expertise in the medical device industry on an hourly rate contracting basis. In this role, you'll be a key player in ensuring our manufacturing processes are robust, compliant, and efficient.
Responsibilities:
- Develop and approve validation protocols (IQ, OQ, PQ) and process characterization reports.
- Write, review, and approve Repeat Action Assessments (RAA) and Acceptance Equipment Lists (AELs).
- Update, review, and approve manufacturing instructions (SGOIs) and Manufacturing Execution System (MES) documents.
- Serve as the primary owner for DMR remediation NC/CAPAs as needed.
- Contribute to the completion of all DMR remediation activities, ensuring they are completed within required timelines.
What We're Looking For:
- A minimum of 2+ years of experience in a manufacturing, quality, or new product introduction (NPI) role within the medical device sector.
- Familiarity with medical device manufacturing documentation, including Standard Operating Procedures (SOPs), change control, and process risk assessments (PFMEA).
- Strong understanding of validation documentation (IQ, OQ, PQ) and their application.
- Experience with Design Master Record (DMR) remediation projects is a plus.
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