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…