Quality Manager

Actalent; Maple Grove (MN); On-site; USD 120,000 - 145,000; Full time

Benefits offered by this job

Medical

Dental

Vision

FSA

Basic Life

401(k)

Paid Holidays

PTO

Maternity/Paternity paid leave

Job summary

Actalent in Maple Grove, MN, seeks a Quality Manager to lead quality operations for a structural heart medical device program advancing through pivotal clinical trials toward global commercialization. This senior role oversees manufacturing quality, inspection, investigations, and quality systems, guiding a team of professionals responsible for Class III implants.

You will drive CAPA, support supplier quality, ensure regulatory readiness with FDA, ISO 13485, MDSAP, and collaborate across

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or related technical discipline.
• 7+ years in Quality Engineering/QA/Manufacturing Quality in regulated industry.
• Experience in FDA-regulated medical device manufacturing.
• Knowledge of CAPA, nonconformance management, root cause analysis, and regulatory compliance.
• Experience leading investigations and driving CAPA.
• Proven people leadership or team management experience.
• Strong understanding of manufacturing quality, inspection methods, process controls, and quality improvement.
• Excellent cross-functional communication.

Responsibilities

• Lead quality operations supporting manufacturing, inspection, testing, and release activities.
• Ensure compliance with FDA, ISO 13485, MDSAP, and applicable regulations.
• Maintain audit and inspection readiness.
• Lead investigations of nonconformances, deviations, complaints, and quality events.
• Drive CAPA from investigation through implementation and verification.
• Partner with manufacturing to improve process capability and product quality.
• Oversee environmental monitoring, cleanroom controls, and manufacturing quality processes.
• Support supplier quality initiatives and incoming inspection strategies.
• Develop and coach quality engineers and inspectors, fostering continuous improvement.
• Monitor quality metrics and identify opportunities to improve efficiency and compliance.
• Collaborate across functions to support clinical, regulatory, and commercialization objectives.

Skills

Leadership

CAPA

Nonconformance management

Root cause analysis

Regulatory compliance

Investigations

Cross-functional collaboration

Manufacturing quality

Education

Bachelor's degree in Engineering/Life Sciences/Quality

Job description

Are you passionate about building quality into breakthrough medical technologies? We're seeking a Quality Manager to lead quality operations for an innovative structural heart medical device program advancing through pivotal clinical trials and toward global commercialization. In this highly visible leadership role, you will oversee manufacturing quality, inspection, compliance, investigations, and quality systems while leading a team of quality professionals supporting the production of Class III implantable medical devices. This is an opportunity to influence product quality, regulatory readiness, and operational excellence while helping bring life-changing cardiovascular therapies to patients around the world.

What You'll Do

• Lead quality operations supporting manufacturing, inspection, testing, and release activities.
• Ensure compliance with FDA, ISO 13485, MDSAP, and applicable international regulations.
• Maintain a continuous state of audit and inspection readiness.
• Lead investigations involving nonconformances, deviations, complaints, and quality events.
• Drive CAPA activities from investigation through implementation and effectiveness verification.
• Partner with manufacturing teams to improve process capability, product quality, and operational performance.
• Oversee environmental monitoring, cleanroom controls, and manufacturing quality processes.
• Support supplier quality initiatives, including supplier corrective actions and incoming inspection strategies.
• Develop and coach quality engineers and quality inspectors while fostering a culture of accountability and continuous improvement.
• Monitor quality metrics and identify opportunities to improve efficiency, compliance, and product quality.
• Collaborate across functions to support clinical, regulatory, and commercialization objectives.
• Contribute to long-term quality strategy while remaining actively involved in day-to-day operations.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline.
• 7+ years of experience in Quality Engineering, Quality Assurance, Manufacturing Quality, or Quality Operations within a regulated industry.
• Experience working in FDA-regulated medical device manufacturing environments.
• Strong knowledge of quality systems, CAPA, nonconformance management, root cause analysis, and regulatory compliance.
• Experience leading investigations and driving corrective and preventive actions.
• Prior people leadership or team management experience.
• Strong understanding of manufacturing quality, inspection methods, process controls, and quality improvement methodologies.
• Excellent communication and cross-functional collaboration skills.

Preferred Qualifications

• Experience supporting Class III or implantable medical devices.
• Cardiovascular, structural heart, electrophysiology, orthopedic, neuromodulation, or other complex medical device experience.
• Experience supporting products through clinical studies and commercialization.
• Familiarity with MDSAP, EU MDR, and Health Canada requirements.
• Experience working in cleanroom manufacturing environments.
• Experience with supplier quality and critical component management.
• Knowledge of risk management, validation, design controls, and design assurance principles.
• Proven success in fast-paced or high-growth medical device organizations.

Don't meet every qualification? We encourage you to apply. We value diverse medical device backgrounds and recognize that strong candidates may bring transferable experience from other highly regulated product environments.

Job Type & Location

This is a Permanent position based out of Maple Grove, MN.

Pay And Benefits

The pay range for this position is $120000.00 - $145000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

We recognize that meaningful work is supported by meaningful benefits. That’s why we offer a competitive compensation package along with comprehensive benefits designed to support you and your family’s health, well-being, and financial future. Our benefits package includes:

• Medical
• Dental
• Vision
• Flexible Spending Account (FSA)
• Basic Life
• 401(k) Retirement Plan
• Paid Holidays
• PTO
• Maternity/Paternity paid leave Workplace Type This is a fully onsite position in Maple Grove,MN. Application Deadline This position is anticipated to close on Oct 2, 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 [e-mail] 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.