Senior Quality Engineer (CMO & Operations Scale-Up)
Join an exciting, fast-moving startup Medical Device company in a pivotal growth phase.
We are preparing to commercialize a novel product and are building out the operational infrastructure to support rapid scaling.
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.
We are seeking an autonomous and highly experienced Senior Quality Engineer with deep expertise in Operations Quality and New Product Introduction (NPI).
This role requires a 'quality-first' mindset and a proven ability to manage complex compliance requirements across multiple external vendors.
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.
Key Responsibilities
Contract Manufacturer Oversight:
Serve as the core Quality contact, assessing and ensuring the manufacturing contractor's processes and systems meet all quality controls.
Global Compliance:
Ensure comprehensive compliance with
FDA QSR (21 CFR Part 820), ISO *****, EU MDR, and ISO ***** (Risk Management)
as the product is commercialized across global markets.
Validation & NPI:
Develop, implement, and maintain
process validation (IQ/OQ/PQ), equipment qualification
, and test method validation in close partnership with the CMO.
Systemic Improvement:
Lead
CAPA investigations
stemming from operations and supply chain, driving
root cause analysis
and implementing effective corrective actions.
Supplier Quality Management:
Support all aspects of
supplier qualification, auditing, and ongoing performance monitoring
of key raw material suppliers and contractors.
Data Analysis:
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.
Audit Support:
Actively participate in internal and external audits (
FDA, Notified Bodies, ISO, MDSAP
).
Qualifications & Skills
Education:
Bachelor's degree in Engineering, Life Sciences, or a related technical field.
Experience:
Minimum
5–8 years of quality engineering experience
in the medical device industry.
Required Depth:
Proven experience in both
New Product Development Quality
and
Post-Market Quality
with strong knowledge of Operations functions.
Hands-on Expertise:
Practical, hands-on experience is essential across
Design Controls, Process Validation, Production Controls, Risk Management, CAPA, and Supplier Quality
.
Analytical Proficiency:
Demonstrated proficiency with
statistical analysis tools
and quality tools (FMEA, SPC, Root Cause Analysis).
Leadership:
Demonstrated ability to
lead cross-functional projects
and influence decision-making with a strong problem-solving and analytical approach.
Ready to be the Quality Anchor for an innovative MedTech launch?
This critical role offers high visibility and the chance to own the quality framework from scale-up to market maturity.
Apply in confidence today or contact James Cassidy for more details.
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