Pilot Operations Senior Quality Engineer
Irvine, CA
Schedule:
Standard Office Hours
Duration:
8-Month Contract
Pay:$54-59/ph
Join a leading medical device organization in advancing next-generation technologies. This role supports the development of delivery systems for clinical manufacturing in the structural heart space, contributing directly to innovative solutions for patients worldwide.
Job Responsibilities:
In this role, you will support product development and pilot operations within the Quality Engineering department. Key responsibilities include:
- Partnering with cross-functional teams to ensure compliance and implementation of quality operations for pilot manufacturing.
- Supporting new product development for early-stage programs including feasibility, early human use, and clinical study builds.
- Facilitating transfer activities from pilot operations to commercial manufacturing facilities.
Essential Duties and Job Functions:
- Navigate the internal Quality System to support the timely manufacture of test and human-use products.
- Conduct risk assessments on new manufacturing processes (e.g., PFMEAs, live process reviews).
- Lead test method development and validation for in-process inspection procedures.
- Analyze and resolve complex quality issues including CAPAs, non-conformances, and audit observations.
- Drive improvements in inspection techniques and manufacturing processes.
- Lead Material Review Board (MRB) meetings and make disposition decisions on potentially non-conforming product.
- Monitor quality performance metrics (e.g., yields, defect rates) and contribute to data-driven continuous improvement initiatives.
Knowledge & Skills:
- Strong understanding of Quality Engineering principles, medical device regulations (e.g., FDA), and risk management.
- Experience with computerized Manufacturing Execution Systems (MES) preferred.
- Proficiency in statistical analysis and data visualization (Minitab experience preferred).
- Ability to work cross-functionally and communicate effectively across all levels of the organization.
- Strong leadership, problem-solving, and decision-making capabilities.
- Comfortable managing multiple priorities in a fast-paced, collaborative environment.
Education & Experience:
- Bachelor’s degree in Engineering with a minimum of 4 years of medical device industry experience; or
- Master’s degree in Engineering with a minimum of 3 years of medical device industry experience.
- Experience in pilot or early-phase manufacturing strongly preferred.
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