About the job
We are seeking Manufacturing/Quality Engineers to support a large-scale remediation initiative within the medical device industry. This contract role offers the opportunity to work directly on production line processes, ensuring compliance, robustness, and efficiency across a wide variety of products. You will collaborate closely with cross-functional teams in Manufacturing and Quality Engineering, receiving clear direction and support to help drive remediation deliverables forward.
Key Responsibilities:
- Review, assess, and update manufacturing processes, with a focus on risk assessment (PFMEA) and process validation (IQ, OQ, PQ).
- Write, review, and approve validation protocols, process characterization reports, Repeat Action Assessments (RAA), and Acceptance Equipment Lists (AELs).
- Update, review, and approve Manufacturing Instructions (SGOIs) and MES documents.
- Support Device Master Record (DMR) remediation activities, including owning NC/CAPA actions as needed.
- Ensure all remediation activities are delivered within defined timelines.
- Collaborate daily with Manufacturing Engineers and Quality Engineers to optimize line processes.
What We're Looking For:
- 2+ years of experience in medical device manufacturing, quality, or new product introduction (NPI).
- Hands-on experience supporting manufacturing lines in a regulated environment.
- Strong background in process validation (IQ, OQ, PQ) and risk assessment (PFMEA).
- Familiarity with controlled manufacturing documentation (e.g., SOPs, change control, MES).
- CAPA experience is an advantage but not required.
- Ideal background: Manufacturing Engineer or Quality Engineer with medical device exposure.
