Quality Engineer
Content + Source + Freshness • 16 Dec 2025 • 95% confidence
Offer value
Moderate value primarily due to the competitive nature of contract positions in medical device quality engineering and significant hands-on responsibilities.
- Great role for engineers looking to enhance compliance experience
- Involvement in substantial remediation initiatives
- Offers collaborative experience in a team-oriented environment
Pros
- Hands-on experience on large-scale remediation projects
- Potential for skill enhancement in a regulated environment
- Opportunities for collaboration across teams
Cons
- Contract position with uncertain long-term stability
- May require extensive hours and tight deadlines due to project demands
- Limited remote work options might impact work-life balance
Who it's for
Mid-level • In-office
Good fit
- Mid-level quality engineers in medical device sectors
- Professionals interested in compliance-based roles
- Individuals who excel in challenging project environments
Not recommended for
- Entry-level professionals without related experience
- Candidates interested in fully remote positions
- Those looking for predictable work hours
Motivation fit
Key skills
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.
