Senior Quality Engineer – Medical Devices
Onsite role, Monday – Friday
Employment Type: Full time
Our direct client is a Senior Quality Engineer to join an innovative 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.