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Company:
Compunnel
Posted: April 18, 2025
Job Summary
The Pilot Operations Senior Quality Engineer will partner with cross-functional teams to support the clinical manufacturing of delivery systems within Client ’ Transcatheter Heart Valve (THV) Business Unit. This role plays a pivotal part in advancing life-saving technologies through quality oversight, process improvement, and compliance with regulatory standards in a fast-paced, high-impact environment. The ideal candidate brings experience in medical device manufacturing and is passionate about helping patients live longer, healthier lives.
Key Responsibilities
Certification: Six Sigma , Certification in Quality Engineering
The Pilot Operations Senior Quality Engineer will partner with cross-functional teams to support the clinical manufacturing of delivery systems within Client ’ Transcatheter Heart Valve (THV) Business Unit. This role plays a pivotal part in advancing life-saving technologies through quality oversight, process improvement, and compliance with regulatory standards in a fast-paced, high-impact environment. The ideal candidate brings experience in medical device manufacturing and is passionate about helping patients live longer, healthier lives.
Key Responsibilities
- Guide new product development teams through the Client Quality System to ensure timely and compliant manufacturing of test and clinical-use products.
- Support early-stage manufacturing including feasibility studies, system test builds, and clinical sample production.
- Perform risk assessments such as PFMEAs and live manufacturing process reviews.
- Lead efforts to investigate and resolve quality issues including CAPAs, non-conformances, and audit observations.
- Develop and validate in-process inspection test methods.
- Facilitate Material Review Board (MRB) decisions on potentially non-conforming clinical products.
- Track and report product yields and defect trends; use data to drive continuous improvement initiatives.
- Contribute to the transfer of products from Pilot to full-scale manufacturing.
- Partner with operations, engineering, and regulatory teams to maintain compliance and quality objectives.
- Bachelor’s Degree in an Engineering discipline and a minimum of 4 years of experience in the medical device industry
- OR
- Master’s Degree in an Engineering discipline and a minimum of 3 years of experience in the medical device industry
- Experience with risk management, quality compliance, and statistical analysis (Minitab preferred)
- Understanding of FDA regulations and Quality Systems related to the medical device industry
- Familiarity with Manufacturing Execution Systems (MES) preferred
- Prior experience in Pilot or clinical manufacturing environments
- Knowledge of inspection methods, test method validation, and process improvement methodologies
- Experience working on cross-functional teams in a regulated industry
- Certification in Quality Engineering (CQE), Six Sigma, or related discipline is a plus
- Strong attention to detail and organizational skills
- Excellent analytical, problem-solving, and decision-making abilities
- Effective verbal and written communication skills across all levels of the organization
- Proven ability to influence, lead, and collaborate across departments in a high-paced environment
- Ability to manage multiple priorities while maintaining quality and compliance focus
Certification: Six Sigma , Certification in Quality Engineering
Read the full job description and apply online on the recuiter's web-site
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