Quality Engineer- Medical Device- Northborough, Ma

As the Quality Engineer you will gain hands on experience in medical device development, focusing on manual testing, design controls, sterilization, and transit testing. You will collaborate closely with mechanical engineers and cross functional teams to ensure compliance with FDA regulations and ISO 13485 standards.

Client Details

Our client is a global leader in advanced engineering, prototyping, product development, and micro-manufacturing, specializing in the medical device industry. With a commitment to innovation, quality, and speed, they collaborate closely with customers to bring breakthrough medical products to market efficiently. Operating across 17 facilities worldwide, they offer comprehensive solutions from initial concept to high-volume manufacturing.

Description

• Ensure adherence to Design Controls per ISO 13485:2016 and QSR 21 CFR 820, along with other product regulatory requirements.

• Apply advanced tools and methods to identify and realize new products or process introductions, driving business improvements.

• Lead and contribute to the application of risk management and risk mitigation tools and practices.

• Conduct root cause investigations using various problem-solving techniques and assess the effectiveness of corrective actions.

• Develop and support the development of test methods in equipment, process, and product qualifications/validations.

• Develop, implement, and maintain process Quality control plans in accordance with product utilization and risk level.

• Develop, review, implement, and maintain process controls using appropriate techniques and tools, such as Statistical Process Controls and statistical inspection sampling.

• Lead or participate in design/technical reviews as appropriate.

• Interpret and implement standard and non-standard sampling plans.

• Act as a subject matter expert in at least two routine Quality areas.

• Partner with technical leaders to develop innovative approaches for identifying technical opportunities and quality improvements.

Profile

• Familiarity with ISO 13485:2016 standards and FDA 21 CFR 820 regulations.

• Experience in Quality Engineering within a medical device manufacturing environment.

• Strong technical writing and communication skills.

• Proficiency in statistical software (e.g., Minitab) and data analysis.

• Bachelor's degree in Engineering or a related field, or equivalent experience.

• Professional interaction with customers and suppliers; proactive communication to ensure continuous information exchange.

• Experience in auditing and qualifying new suppliers is a plus.

• Certified Quality Engineer (CQE) and/or Six Sigma certification.

• Bachelor's degree in Physics, Optics, Mechanical, Chemical, Plastics, or a related Engineering discipline.

• Exceptional attention to detail and organizational skills; ability to self-manage project tasks.

• Position involves minimal office work; may include up to 10% domestic and international travel.

Job Offer

• Profit Sharing Bonus: Earn an annual 3-4% bonus based on company performance.

• Growing Company: Be part of a medium-sized company with 2,000-2,800 employees, experiencing continuous growth.

• Career Advancement: Opportunities to transfer within the company as new sites open.

• Comprehensive Benefits: Enjoy a competitive benefits supporting your health and well-being.

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.