Senior Quality Engineer Opportunity
We are seeking an experienced Senior Quality Engineer to join our team in a pivotal growth phase. This is a unique opportunity to act as the primary Quality liaison with our contract manufacturing partners, directly influencing product quality, efficiency, and global regulatory compliance from the ground up.
Key Responsibilities:
* Serve as the core Quality contact, assessing and ensuring the manufacturing contractor's processes and systems meet all quality controls.
* Ensure comprehensive compliance with FDA QSR (21 CFR Part 820), ISO 13485, EU MDR, and ISO 14971 (Risk Management) as the product is commercialized across global markets.
* Develop, implement, and maintain process validation (IQ/OQ/PQ), equipment qualification, and test method validation in close partnership with the CMO.
* Lead CAPA investigations stemming from operations and supply chain, driving root cause analysis and implementing effective corrective actions.
* Support all aspects of supplier qualification, auditing, and ongoing performance monitoring of key raw material suppliers and contractors.
* Lead efforts in non-conformance investigations, disposition decisions, and use statistical data analysis (Minitab, FMEA, SPC) to identify trends and systemic issues for product/process improvement.
* Actively participate in internal and external audits (FDA, Notified Bodies, ISO, MDSAP).
Qualifications & Skills:
* Bachelor's degree in Engineering, Life Sciences, or a related technical field.
* Minimum 5 years of quality engineering experience in the medical device industry.
* Proven experience in both New Product Development Quality and Post-Market Quality with strong knowledge of Operations functions.
* Practical, hands-on experience is essential across Design Controls, Process Validation, Production Controls, Risk Management, CAPA, and Supplier Quality.
* Demonstrated proficiency with statistical analysis tools and quality tools (FMEA, SPC, Root Cause Analysis).
* Demonstrated ability to lead cross-functional projects and influence decision-making with a strong problem-solving and analytical approach.
About this role:
This critical role offers high visibility and the chance to own the quality framework from scale-up to market maturity. If you are passionate about taking ownership, resolving issues proactively, and driving a medical device through manufacturing ramp-up, this is your chance to shine.