Quality Engineer

Location: Maple Plain

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.

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