Quality Manager

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

Benefits offered by this job

Medical

Dental

Vision

Flexible Spending Account (FSA)

Basic Life

401(k)

Retirement Plan

Paid Holidays

PTO

Maternity/Paternity paid leave

Job summary

Actalent is seeking a Quality Manager to lead quality operations for a Class III implantable medical device program in Maple Grove, MN. You will oversee manufacturing quality, inspections, investigations, CAPA and compliance activities while enabling clinical studies and commercialization.

You will coach quality engineers and inspectors, drive process improvements, and ensure readiness for FDA and international regulatory inspections in a fast-paced medical device environment.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or related discipline.
• 7+ years in Quality within regulated industry.
• Experience in FDA-regulated medical device manufacturing.
• Strong knowledge of CAPA, nonconformance, root cause, and regulatory compliance.
• Experience leading investigations and driving CAPAs.
• People leadership or team management experience.
• Understanding of manufacturing quality, inspection methods, process controls, and quality improvement methodologies.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Lead quality operations for manufacturing, inspection, testing, and release.
• Ensure FDA/ISO13485/MDSAP regulatory compliance.
• Maintain audit and inspection readiness.
• Lead investigations of nonconformances and quality events.
• Drive CAPA from investigation through 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 quality engineers and quality inspectors while fostering accountability.
• Monitor quality metrics and identify improvement opportunities.
• Collaborate across functions to support clinical, regulatory, and commercialization objectives.
• Contribute to long-term quality strategy while remaining involved day-to-day.

Skills

Quality engineering

Quality assurance

Manufacturing quality

Quality operations

CAPA

Nonconformance management

Root cause analysis

Regulatory compliance

Investigations

People leadership

Process controls

Quality systems

Cross-functional collaboration

Communication skills

Class III devices

Education

Bachelor's degree in Engineering, Life Sciences, Quality, or related discipline

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.

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.

• 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 22, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions.

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.