Quality Engineer
We are seeking a Quality Engineer to support the quality assurance aspects of a manufacturing ramp-up.
About This Role
This is an exciting opportunity for a quality professional who is proactive, detail-oriented, and confident in a cross-functional production setting.
Key Responsibilities
* Provide quality support during the scale-up of production activities and station commissioning.
* Collaborate with the manufacturing and quality teams to ensure adherence to regulatory and internal quality standards.
* Investigate and document quality issues, including vendor deviations, operator/process errors, and equipment malfunctions.
* Lead and support the execution of CAPAs, non-conformances, deviations, and associated investigations.
* Maintain and improve quality documentation, protocols, and reports.
* Support the qualification of new equipment and processes.
Ideal Candidate
To be successful in this role, you will need:
* 2-3+ years of experience in a quality engineering role in MedTech, pharma, or biotech.
* Solid knowledge of QA and regulatory requirements (e.g., ISO 13485, FDA QSR).
* Experience supporting production environments and working closely with operators, technicians, and engineers.
* Excellent documentation and investigation/report writing skills.
* Familiarity with electronic systems (e.g., firmware, software, hardware) used in production or devices - technical appreciation but not necessarily expertise.
What We Offer
We offer a dynamic and supportive work environment where you can grow your career and contribute to the development of medical device products.