Senior Quality Engineer

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