Medical Device Quality Control Technologist

Job Description

Job Description

Job Description

This QC Lab Technician role supports process and product quality testing by preparing equipment, samples, and materials for submission to external laboratories for further analysis. The position combines hands-on laboratory work, cleanroom environmental monitoring, and detailed documentation to ensure products meet stringent quality and regulatory standards. You will work closely with production, quality, and third-party labs while contributing to a collaborative, training-focused culture with opportunities for growth within the Quality function.

Responsibilities

• Collect, prepare, and submit samples to various laboratories for further analysis, ensuring proper labeling, documentation, and chain-of-custody.
• Verify and analyze test results from internal and external laboratories, escalating any out-of-specification findings according to procedures.
• Prepare and mix chemical formulations for production and manufacturing use, following established Standard Operating Procedures (SOPs).
• Perform in-process quality control tasks to support ongoing manufacturing operations and ensure products meet defined specifications.
• Maintain maintenance records for all laboratory and quality control equipment, ensuring equipment remains calibrated and in good working order.
• Perform environmental monitoring of cleanrooms, including humidity and temperature checks, and ensuring pest control measures are in place and documented.
• Conduct daily pre-operational quality control checks of passivation chemistry to confirm readiness for production.
• Perform package visual inspections and conduct seal strength and integrity testing on pouches and sterile seals.
• Use measurement equipment such as micrometers, calipers, and rulers to verify dimensional and quality attributes.
• Review sterilization certificates to determine whether product can be fully released in accordance with quality requirements.
• Review lot history records (LHRs) for completeness, accuracy, and compliance with quality system requirements.
• Maintain accurate, detailed records of all laboratory activities, test results, and inspections in accordance with quality documentation standards.
• Support quality control investigations and corrective and preventive actions (CAPAs), including gathering data, documenting findings, and implementing approved actions.
• Verify that quality control measurements are accurate and ensure results are documented with strong attention to detail.
• Ensure inspections are completed on time and aligned with priorities and production schedules, helping to prevent delays in manufacturing and product release.
• Review manufacturing records, including sterile processing data, test results, certifications, labeling, and paperwork to ensure compliance with specifications and quality system requirements.
• Partner with third-party laboratories to coordinate testing, clarify requirements, and ensure timely receipt and review of results.
• Enter, review, and manage data in computer systems for quality records, test results, and reports, dedicating approximately half of the role to computer-based work.
• Support a culture of quality by speaking up when something is out of scope or not aligned with procedures, and by consistently following SOPs.

Essential Skills

• Bachelor’s degree in a science discipline.
• At least 6 months of experience in environmental monitoring and/or sterilization activities.
• Hands-on experience with environmental monitoring in cleanrooms, including humidity and temperature monitoring and awareness of pest control measures.
• Experience performing or supporting microbiological testing such as bioburden and plating.
• Experience in quality control or quality assurance within a laboratory or manufacturing environment.
• Ability to follow Standard Operating Procedures (SOPs) consistently, as verified by references.
• Demonstrated commitment to quality, including a willingness to speak up when something is out of scope or non-compliant.
• Ability to perform in-process quality control tasks and interpret test results.
• Proficiency in using measurement tools such as micrometers, calipers, and rulers.
• Strong documentation skills with the ability to maintain accurate and complete records.
• Comfort working with computer systems to verify measurements, document results, and review manufacturing and quality records.
• Attention to detail and organizational skills to ensure inspections and documentation meet quality system requirements.

Additional Skills & Qualifications

• Experience with bioburden testing, microbiology techniques, and laboratory-based quality control activities.
• Familiarity with TOC device extraction, pH testing, FTIR, water collection for bioburden, and air particulate testing.
• Experience performing environmental monitoring in cleanroom environments within manufacturing or medical device settings.
• Exposure to QC investigations and participation in corrective and preventive actions (CAPAs).
• Experience reviewing sterilization certificates and manufacturing records for product release.
• Ability to work cross-functionally and wear multiple hats, supporting different areas of the operation as needed.
• References who can speak to a strong quality mindset, reliability, and adherence to SOPs.
• Interest in career advancement within Quality after gaining at least two years of experience in this role.

Work Environment

This role is fully on-site at a facility in St. Paul, Minnesota, with approximately 50% of the time spent in the laboratory and cleanroom environment and 50% at a desk performing computer-based work and documentation. The organization operates as a small, family-run company fostering a close-knit, collaborative culture where employees often support different functions and wear multiple hats. The work schedule follows an on-site day shift, typically from 8:00 a.m. to 4:30 p.m., Monday through Friday. The company places strong emphasis on training and invests heavily in onboarding and developing new hires, offering clear pathways for career growth within the Quality function. The environment involves working with laboratory equipment, measurement tools, and cleanroom spaces, and requires adherence to established procedures and quality system requirements.

This is a Permanent position based out of Saint Paul, MN.

The pay range for this position is $52000.00 - $62400.00/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.

Benefits include medical, dental, vision and life insurance. Additionally they offer a 401K, with company match of up to 4%. They also have profit sharing

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

This position is anticipated to close on Sep 23, 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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.