A leading medical device manufacturer is seeking a Senior Quality Engineer to drive quality system compliance and process development, ensuring alignment with ISO 13485 and FDA regulations. This role focuses on continuous improvement, process validation, and cross-functional collaboration to support high-performance manufacturing and regulatory excellence. Client Details Our client is a global leader in advanced engineering, micro-manufacturing, and product development for the medical device industry. Known for its innovative technology and rapid growth, the company fosters a collaborative, employee-focused culture committed to quality, precision, and continuous improvement. Description Responsibilities as a Sr. Quality Engineer: Lead cross-functional teams to ensure robust quality systems and defect-free product development aligned with business and customer expectations.

Ensure compliance with ISO 13485, 21 CFR 820, and internal product development processes.

Drive continuous improvement and process validation using tools such as DOE, FMEA, Gage R&R, and quality plans.

Review and approve validation protocols, investigations, and quality procedures.

Act as a subject matter expert during audits and inspections, including interfacing with the FDA and other regulatory bodies.

Mentor and train engineers and technicians on quality methodologies and regulatory standards.

Profile Requirements for the Sr. Quality Engineer Position: Bachelor's degree in Engineering or a related field; ASQ certification or Six Sigma Green Belt preferred.

Minimum 7 years of experience in a Quality Engineering role within the medical device industry or a similar manufacturing environment.

Strong knowledge of ISO 13485, 21 CFR 820, and application of quality tools such as Six Sigma, DOE, and FMEA.

Demonstrated ability to manage multiple projects while ensuring compliance and driving continuous improvement.

Excellent technical writing, communication, and cross-functional collaboration skills

Job Offer Whats on offer for you: Work for a fast-growing, innovative leader in medical device manufacturing.

Receive competitive pay with comprehensive benefits and paid time off.

Thrive in a collaborative environment focused on growth and learning.

Contribute to high-quality products that improve patient care.

Gain mentorship and development opportunities with industry experts.

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.