Michael Page
- Great Leadership
- Well Performing & Supportive Culture
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.
Job 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.
The Successful Applicant
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
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.
Contact
Bridget Petti
Quote job ref
JN-072025-6799519