Our direct client is a Senior Quality Engineer to join an cutting-edge medical device organization developing cutting-edge diagnostic technologies. This is a highly visible, hands‑on role focused on supporting manufacturing operations and partnering closely with R&D; to successfully transfer new products into production.
This is an excellent opportunity for a seasoned Quality Engineer who thrives in a manufacturing environment and enjoys taking ownership of process improvements, validations, and product commercialization.
Required Qualifications
- 10+ years of Quality Engineering experience within the medical device industry.
- Strong manufacturing quality experience (preferred over product design quality).
- Proven experience supporting design transfer from R&D; into manufacturing.
- Experience with process validations, test methods, characterization studies, and process capability.
- Experience working with supplier quality and manufacturing engineering teams.
- Experience with medical device hardware/instrumentation is required.
- Excellent problem‑solving, communication, and cross‑functional collaboration skills.
Nice to Have
- Experience with diagnostic medical devices.
- Experience supporting assay-based products or IVD technologies.
Key Responsibilities
- Partner with R&D; teams on design transfer activities and new product introductions.
- Lead quality engineering efforts to support manufacturing scale‑up and production readiness.
- Develop and improve test methodologies and product characterization activities.
- Conduct process capability studies and analyze manufacturing data to drive continuous improvement.
- Lead equipment, process, and product validation activities (IQ/OQ/PQ).
- Collaborate with Manufacturing Engineering to optimize production processes.
- Support supplier quality initiatives, including supplier qualification and performance improvement.
- Ensure compliance with quality system requirements and applicable medical device regulations.