Quality Engineer

Job Title:

Quality Engineer

Job Description

This Quality Engineer role focuses on owning and driving Corrective and Preventive Action (CAPA) activities end-to-end, managing non-conforming material reports, and supporting design quality across the product lifecycle in a regulated medical device environment. You will collaborate closely with Engineering, Regulatory, and Operations teams to resolve quality issues, identify process gaps, and implement sustainable improvements. This position offers the opportunity to take ownership of critical quality processes, contribute directly to product quality and patient outcomes, and grow within a collaborative, mission-driven team.

Responsibilities

+ Own and drive CAPA activities from initiation through investigation, root cause analysis, implementation of actions, verification of effectiveness, and closure.

+ Manage and resolve Non-Conforming Material Reports (NCMRs), including documentation, disposition, and follow-up actions.

+ Support Design Quality efforts across the product lifecycle with a focus outside of manufacturing operations, ensuring quality is built into product design and development.

+ Collaborate cross-functionally with Engineering, Regulatory, and Operations teams to investigate and resolve quality issues efficiently and effectively.

+ Identify gaps in quality processes and proactively propose, implement, and sustain improvements to enhance overall quality system performance.

+ Operate with a strong sense of urgency to ensure timely resolution of quality events and minimize impact on products and customers.

+ Balance hands-on execution and appropriate delegation while remaining directly involved in technical work and critical decisions.

+ Conduct thorough quality investigations, analyze data, and document findings in a clear, compliant, and structured manner.

+ Support both technical execution and process ownership, ensuring that quality procedures are followed and continuously improved.

+ Adapt quickly to a fast-paced, evolving environment and contribute to building scalable quality processes for a growing organization.

Essential Skills

+ 2-6+ years of experience in Quality Engineering within medical devices or a regulated industry.

+ Proven, hands-on experience managing CAPAs and quality investigations independently from start to finish.

+ Experience working with Non-Conforming Material Reports (NCMRs), including investigation and resolution.

+ Exposure to Design Quality principles, with a focus beyond manufacturing and operations.

+ Strong problem-solving skills with the ability to think critically through complex quality issues.

+ Demonstrated ability to work independently with limited direction while delivering high-quality results.

+ Excellent communication skills, both written and verbal, with the ability to present findings clearly.

+ Strong cross-functional collaboration skills, with experience partnering with Engineering, Regulatory, and Operations teams.

Additional

Skills & Qualifications

+ Experience working in a Contract Manufacturer (CMO) or small to mid-sized medical device company.

+ Comfort working in fast-paced, evolving environments with a high degree of ambiguity.

+ Demonstrated ability to hit the ground running and quickly become effective in new roles.

+ Prior experience supporting both detailed technical execution and broader process ownership responsibilities.

+ Motivation to take ownership, build and refine quality processes, and contribute to a mission-driven culture.

+ Interest in opportunities for equity participation upon full-time conversion, where applicable.

Work Environment

You will work in a growing, innovative medical device environment that emphasizes collaboration, ownership, and continuous improvement. The culture is mission-driven, with a clear focus on improving product quality and patient outcomes. The organization operates in a fast-paced, evolving setting where ambiguity is common and adaptability is valued. Core collaboration hours are 9:00 AM to 3:00 PM, with flexibility outside of these hours to support work-life balance and accommodate different working styles.

The role involves close interaction with cross-functional teams, modern quality systems, and regulated processes typical of medical device development and manufacturing.

Job Type & Location

This is a Contract to Hire position based out of Saint Paul, MN.

Pay and Benefits

The pay range for this position is $45.00 - $60.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:  - Medical, dental & vision  - Critical Illness, Accident, and Hospital  - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available  - Life Insurance (Voluntary Life & AD&D for the employee and dependents)  - Short and long-term disability  -…