Quality Engineer

Quality Engineer - New Product Introduction

We"re looking for a Quality Engineer who thrives on solving complex problems, driving meaningful improvements, and influencing product quality from development through commercialization. In this role, you"ll take ownership of critical quality initiatives, partner closely with Engineering and Regulatory teams, and help ensure safe, effective medical device products reach patients. This is an exciting opportunity for someone who enjoys working in a growing, innovative environment where they can make a visible impact, improve quality systems, and help shape processes as the organization continues to scale.

What You"ll Do

As our Quality Engineer, you"ll play a key role in maintaining and improving the effectiveness of our Quality Management System while partnering with cross-functional teams to investigate issues, drive improvements, and support product quality.

• Lead Corrective and Preventive Action (CAPA) activities from investigation through implementation and closure.
• Conduct root cause investigations and partner with stakeholders to identify effective corrective actions.
• Manage Non-Conforming Material Reports (NCMRs), ensuring timely review, disposition, and resolution.
• Support design quality activities throughout the product lifecycle, helping ensure compliance and product reliability.
• Collaborate with Engineering, Regulatory Affairs, Operations, and Manufacturing partners to address quality issues and drive continuous improvement.
• Identify opportunities to strengthen quality processes, improve efficiency, and reduce risk.
• Support quality system initiatives and help maintain compliance with applicable regulations and standards.
• Analyze quality trends and data to proactively identify potential issues and improvement opportunities.
• Contribute to a culture of quality, accountability, and continuous learning across the organization.

What We"re Looking For

Required Qualifications

• Bachelor"s degree in Engineering, Quality, Life Sciences, or a related technical field.
• 2+ years of experience in Quality Engineering within medical devices, biotech, life sciences, or another regulated industry.
• Experience managing CAPAs and quality investigations.
• Experience with nonconformance management and quality systems.
• Strong root cause analysis and problem-solving skills.
• Ability to independently manage projects while collaborating effectively across teams.
• Excellent communication skills and the ability to work with technical and non-technical stakeholders.
• Working knowledge of FDA, ISO 13485, or other regulated quality environments.

Preferred Qualifications

• Experience supporting design quality activities or product development programs.
• Experience in a startup, growth-stage company, CMO environment, or small-to-mid-sized medical device organization.
• Experience improving or building quality processes and systems.
• Familiarity with risk management and product lifecycle quality activities.

Why Join Us?

• Opportunity to own impactful quality initiatives and influence product quality decisions.
• Highly collaborative environment with direct interaction across Engineering, Quality, Regulatory, and Operations.
• Exposure to both technical quality work and strategic process improvement efforts.
• Ability to grow your career within a rapidly evolving medical device organization.
• Mission-driven team focused on improving patient outcomes.
• Potential eligibility for equity participation upon full-time conversion, subject to company policies.

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Job Type & Location

This is a Permanent 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 • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Saint Paul,MN.

Application Deadline

This position is anticipated to close on Aug 21, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

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.