I am working with a client that is a leader in medical device design and manufacturing, looking for a Quality Engineer to join their team. This candidate will collaborate within cross-functional teams and uphold impeccable quality systems and regulatory standards throughout each project's lifecycle. This is an on-site position. If interested please apply with a most recent copy of your resume.
- Maintain ISO 13485 and FDA QSR Compliant Quality Management System.
- Evaluate material biocompatibility and sterilization methods.
- Design and execute product/process documentation, including inspection plans.
- Conduct feasibility studies to ensure design functionality.
- Bachelor's degree in a scientific/engineering discipline or AA/AS degree with relevant experience.
- 0-2 years' recent medical device industry exposure, preferably in catheter-based/disposables. Cardiovascular experience is a plus.
- Familiarity with FDA medical device Quality Systems Regulations and international quality system standards (QSR/ISO 13485).
- Ability to engage professionally with client companies.
- A blend of passion, persistence, resourcefulness, and an entrepreneurial spark.
- Communicate technically and professionally in verbal and written formats.
- Efficiently manage resources and prioritize tasks.
- Exceed customer expectations with prompt, reliable, and professional service.
- Listen actively and diplomatically resolve discrepancies.
- Demonstrate initiative, creativity, and organization