Senior Quality Engineer (Medical Devices)

Position: Pilot Operations Senior Quality Engineer, Req#: 10786-1

Location: Irvine, CA (100% Onsite)

Duration: 8 Months Contract

Job Description:

Education and Experience:

• Prior experience in medical device manufacturing or operations preferred
• Experience with computerized Manufacturing Execution System (MES) preferred
• Bachelor's Degree in a relevant Engineering field, plus a minimum of four (4) years of medical device industry experience required
• Master's Degree in a relevant Engineering field, plus a minimum of three (3) years of medical device industry experience required

Job Responsibilities:

• Work with new product development teams to help them efficiently navigate the client’s Quality System in order to build quality system test samples and human-use products according to project schedules
• Identify and ensure implementation of opportunities to optimize/improve manufacturing and inspection processes
• Perform risk assessment on early-stage product manufacturing processes (e.g., PFMEAs, Live Manufacturing Process Reviews)
• Analyze and resolve complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations)
• Develop/drive improvements for inspection test methods
• Lead test method validation activities for in-process inspections
• Facilitate and oversee the Material Review Board to disposition potentially non-conforming human use products
• Track product yields and defect rates. Use data to report metrics at Quality Data Reviews and drive process improvements