Quality Engineer - Medical Devices

• Break Into Medical Device Industry Within This Role|Great Total Package

About Our Client
The company is a leading metal manufacturer of medical devices that is dedicated to providing high-quality products that improve patient outcomes and enhance the quality of life for people around the world. Their state-of-the-art manufacturing facility is equipped with the latest technology and staffed by a team of experienced professionals who are committed to excellence. From the initial design and development phase to the final inspection and testing, the company takes pride in every step of the manufacturing process and holds themselves to the highest standards of quality.
Specializing in producing medical devices that are used in a variety of fields, including orthopedics, cardiology, and neurology, the company's products range from simple instruments to complex implants and are designed to meet the unique needs of their customers and their patients.
The company believes that innovation is key to success in the medical device industry and is always looking for new and better ways to improve their products and manufacturing processes. They invest heavily in research and development to ensure that they stay at the forefront of the industry.
Committed to sustainability and responsible manufacturing practices, the company strives to minimize their environmental impact and operate in an ethical and socially responsible manner.
Above all, their mission is to make a positive impact on the lives of patients worldwide by providing high-quality medical devices that improve health outcomes and enhance quality of life.

• Providing training and guidance to employees on quality control procedures and practices.
• Supporting regulatory submissions and providing documentation to regulatory agencies as needed.
• Keeping up-to-date with changes in regulations and industry standards and ensuring compliance.
• Participating in the review and approval of validation protocols and reports.
• Collaborating with cross-functional teams, including production, engineering, and regulatory affairs, to identify and implement process improvements.
• Investigating and resolving customer complaints related to product quality.
• Conducting audits and inspections to ensure compliance with FDA regulations and ISO standards.
• Developing, implementing, and maintaining quality assurance programs that meet regulatory requirements and customer expectations.
• Participating in risk management activities and assisting in the development of risk management plans.
• Developing and executing quality control plans, including incoming inspection, in-process inspection, and final inspection.
• Contributing to the development and maintenance of the company's quality system.
• Analyzing data and metrics to identify trends and areas for improvement.

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.
The Successful Applicant
As a Quality Engineer for the medical device metal manufacturer, the key responsibilities include:

• Conducting audits and inspections to ensure compliance with FDA regulations and ISO standards.
• Providing training and guidance to employees on quality control procedures and practices.
• Analyzing data and metrics to identify trends and areas for improvement.
• Supporting regulatory submissions and providing documentation to regulatory agencies as needed.
• Participating in risk management activities and assisting in the development of risk management plans.
• Investigating and resolving customer complaints related to product quality.
• Keeping up-to-date with changes in regulations and industry standards and ensuring compliance.
• Developing and executing quality control plans, including incoming inspection, in-process inspection, and final inspection.
• Participating in the review and approval of validation protocols and reports.
• Contributing to the development and maintenance of the company's quality system.
• Developing, implementing, and maintaining quality assurance programs that meet regulatory requirements and customer expectations.
• Collaborating with cross-functional teams, including production, engineering, and regulatory affairs, to identify and implement process improvements.

What's on Offer

• 11 paid Holidays
• 401k of 3% match
• Voluntary benefits through Aflack
• 3 weeks PTO
• Competitive above market compensation

Contact: Jenna Algozine
Quote job ref: JN-052023-6037725