Quality Engineer

Job Title:

Manufacturing Quality Engineer Job Description This Manufacturing Quality Engineer role offers the opportunity to join a fast-scaling medical device organization that combines the agility of a startup with the structure and resources of a global company. You will play a key role in embedding quality into expanding production lines, partnering closely with Manufacturing Engineering, R D, and Process Development. This position is ideal for a hands-on, well-rounded quality engineer who enjoys being on the manufacturing floor, driving practical problem-solving, and building robust, scalable quality processes. In all activities, you will demonstrate a strong commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality procedures. Responsibilities Support and contribute to objectives related to manufacturing product performance, quality, and compliance in a fast-paced, scaling production environment, escalating issues when needed. Participate in lean quality and continuous improvement initiatives, collaborating with manufacturing, engineering, and quality teams to identify opportunities and implement improvements. Investigate and assist in resolving manufacturing and product quality events, including nonconformances, process issues, and customer complaints, and contribute to effective corrective and preventive actions (CAPAs). Own and support manufacturing and receiving quality activities end to end, including nonconformance reports (NCRs), CAPAs, investigations, process changes, and mistake-proofing initiatives. Provide hands-on quality support for key manufacturing processes, including sterile packaging and sterilization activities, to help maintain robust, compliant, and scalable processes. Work closely with Manufacturing Engineering, Process Development, and R D to integrate quality into new and expanding manufacturing lines and to support design assurance activities. Monitor supplier performance metrics and support corrective actions to address quality or delivery discrepancies. Provide technical support on the manufacturing floor and contribute to practical problem-solving efforts, collaborating cross-functionally to identify, assess, and resolve manufacturing and quality challenges. Maintain compliance with quality policies, procedures, and applicable regulatory requirements, consistently supporting a culture of patient safety and product quality. Demonstrate strong ownership of quality processes and maintain a visible daily presence on the manufacturing floor to support operations and drive improvements. Essential Skills Bachelor's degree plus a minimum of 2+ years of related work experience, or an equivalent combination of education and work experience. Experience in quality engineering within a medical device or other regulated industry. Knowledge of quality engineering practices, including CAPA, nonconformance management, and investigations. Self-motivated and capable of managing day-to-day responsibilities with moderate supervision. Ability to multitask, prioritize, and meet deadlines in a timely manner with high attention to detail. Strong written and oral communication skills. Highly organized, accountable, and attentive to detail. Comfort working in a dynamic, fast-growing manufacturing environment with a hands-on approach on the production floor. Additional Skills & Qualifications Four-year engineering degree. Experience owning cross-functional improvement and corrective action projects. Demonstrated project management success, including leading design assurance or similar initiatives. Experience with lean quality principles and continuous improvement in a manufacturing environment. Background in inspection strategy, process changes, mistake-proofing, and quality management system (QMS) development. Ability to collaborate effectively with Manufacturing Engineering, Process Development, R D, and Operations. Interest in working on innovative medical device technologies that significantly impact patient outcomes, such as advanced rotator cuff repair solutions. Work Environment This is an onsite role with standard hours of approximately 8:00 a.m. to 4:00 p.m., with flexibility in start time to accommodate personal needs such as drop-off and pick-up schedules. You will work in a small, fast-scaling medical device manufacturing site where decisions move quickly and impact is highly visible. The environment emphasizes a strong daily presence on the manufacturing floor, close collaboration with cross-functional teams, and direct exposure to senior leadership as the site continues to scale. The facility supports hands-on work with manufacturing processes, including sterile packaging and sterilization activities, within a regulated, quality-focused setting. Job Type & Location This is a Permanent position based out of Maple Plain, MN. Pay and Benefits The pay range for this position is $80000.00 - $145000.00/yr. I have the Benefits guide if candidates are wanting to see benefits in detail Workplace Type This is a fully onsite position in Maple Plain,MN. Application Deadline This position is anticipated to close on May 22, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.