Senior Quality Technician

Job Title: Senior Quality TechnicianJob Description

We are seeking a Manufacturing Quality Senior Technician/Engineer to support the process development of tissue processing and implement quality inspections. The ideal candidate has hands-on experience with structural heart implants and quality inspection processes, and understands GMP requirements for the manufacture of a sterile medical device.

Responsibilities

• Execute lab-based process development runs in a laboratory setting to develop tissue processing of bovine pericardium.

• Implement quality controls during process development to ensure tissue performance, biocompatibility, and repeatability.

• Establish tissue-specific manufacturing procedures, inspection criteria, and in-process controls.

• Develop and maintain relationships with testing vendors for ongoing testing and process development characterization. Maintain test schedules and coordinate sample drop-off and pickup.

• Review technical documentation, such as protocols, reports, and risk files, to support regulatory submissions.

• Think critically and communicate clearly with R&D, Operations, and Regulatory Affairs.

• Drive continuous improvement in quality systems and product development processes.

• Collaborate with Operations and R&D on process development reports.

• Perform other duties as assigned.

Essential Skills

• 3-5 years of experience in quality assurance, with a strong preference for experience in structural heart technologies.

• Experience with the identification and implementation of quality inspections for tissue processing.

• Excellent communication skills with cross-functional teams and vendors.

• Familiarity with FDA QSR, EU MDR, and ISO standards.

• Sound judgment in reviewing technical data, protocols, and reports.

• Ability to handle confidential information and work in a fast-paced, evolving environment.

• Capable of managing multiple priorities and working under pressure.

• Willingness to work in cleanroom environments with bovine pericardium.

Additional Skills & Qualifications

• Knowledge of medical device design assurance, design control, risk management, design validation, and validation processes.

• Proficiency in inspection techniques using micrometers, calipers, and visual inspection methods.

• Experience in calibration and quality checks.

• Strong team-oriented attitude with a focus on small, culture-oriented teams with exciting innovations ahead.

Work Environment

The position is based on-site in Maple Grove, MN, working in a cleanroom environment with bovine pericardium. The team is small and culture-oriented, fostering innovation and collaboration.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $90000.00 - $125000.00/yr.

Medical, dental, vision plans which are effective on your hire date. Health Care Savings Account (HSA) Employee Stock Ownership Program (ESOP) Company Paid Long-Term Disability (LTD) Paid Parental Leave Paid Bereavement Leave Paid Time Off Paid Holidays Employee Assistance Program

Workplace Type

This is a fully onsite position in Maple Grove,MN.

Application Deadline

This position is anticipated to close on Dec 19, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.