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Company: Compunnel
Location: US - California - Irvine
Category:
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
  • 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.
Required Qualifications
  • 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
Preferred Qualifications
  • 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
Certifications (if any)
  • Certification in Quality Engineering (CQE), Six Sigma, or related discipline is a plus
Additional Skills
  • 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
Education: Bachelors Degree

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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