This Product Development Quality Engineer role involves ensuring adherence to strict quality and regulatory standards throughout product and process lifecycles, leading quality initiatives, and driving continuous improvement. Responsibilities also include technical leadership, mentorship, and collaboration with internal and external stakeholders to guarantee the development of high-quality, compliant medical devices

Client Details

This global leader specializes in advanced micro-manufacturing for the medical device industry, partnering with customers to develop innovative technologies that improve patient lives. Their focus is on precision, quality, and regulatory compliance in the creation of critical components and devices.

Description

• Ensuring full utilization of Design Controls per ISO 13485 and QSR 21 CFR 820 throughout product and process development.
• Leading and contributing to risk management, root cause investigations, and the development of test methods and quality control plans.
• Developing, implementing, and maintaining process controls, statistical analysis, and participating in design/technical reviews.
• Acting as a subject matter expert in quality areas, liaising with customers, managing documentation (deviations, validations), and supporting production processes.
• Driving continuous improvement initiatives, conducting training, resolving nonconformances, and contributing to design control deliverables.

Profile

- B.S. degree in engineering or equivalent

- Minimum 2 years' experience in a Quality Engineering role for a medical device manufacturer or equivalent

- Familiarity with ISO 13485 standards and 21 CFR 820 regulation

- Proven ability to be in a customer facing environment and the ability to communicate efficently

Job Offer

• Opportunity for Significant Impact: Directly contribute to the development and quality of innovative medical devices that improve patient outcomes.
• Professional Growth and Leadership: Lead projects, mentor colleagues, and become a subject matter expert, fostering career advancement in a technically challenging environment.
• Comprehensive Involvement in Quality Systems: Engage in all aspects of quality engineering, from design controls and risk management to process validation and continuous improvement.
• Collaborative and Regulated Environment: Work within a team-oriented culture that emphasizes quality and compliance with stringent medical device regulations and industry standards.
• Comprehensive salary and benefits
  

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.