Quality Systems Specialist

Packaging Compliance Labs (PCL) is a medical device packaging testing, engineering, and contract packaging partner with headquarters in Grand Rapids, MI and a testing lab in Billerica, MA. We pride ourselves on taking typical industry challenges and turning them into key differentiators that set us apart from our competitors. This makes PCL a true packaging engineering partner for medical device manufacturers. Our employees embody our five core values: placing patient safety first, becoming the expert, going the extra mile, empowering others for success, and working hard & having fun! By embodying our core values, PCL strives towards our mission to deliver solutions that enable life changing medical innovation.

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For 5 consecutive years, PCL has been added to the "Inc 5000 Fastest Growing Companies" list. We have also been named a 2026 winner for "West Michigan's Best and Brightest Companies to Work For". After over a decade of "working hard and having fun" and half a dozen facility expansions, PCL continues to see rapid growth and we are looking to add a Quality Systems Specialist to our PCL Team!

Essential Responsibilities

• Provide support for laboratory audit and accreditation activities by taking an active role in all client and internal audits
• Train personnel on Quality Management System activities and monitor QMS performance
• Support strategic Quality goals and continuous improvement initiatives
• through document and record management
• Coordinate equipment management activities in collaboration with the Operations team, including equipment validations and calibrations
• Identify and record nonconformities, Quality Events and deviations as needed
• Other Quality and regulatory duties to be assigned as applicable

The Ideal Candidate Will Demonstrate

• Detail-oriented professionalism with a commitment to following quality standards and documentation practices
• Clear communication, both verbal and written, capable of training team members on QMS activities and procedures
• A safety-conscious mindset, taking precautions and being vigilant of others' wellbeing
• Motivation to pursue laboratory technical and quality certifications with management support

Qualifications

• Minimum high school diploma or equivalent; some college, associate degree, or bachelor's degree preferred
• At least two years in a technical or quality field preferred. Medical device and/or cGMP testing experience is a plus
• Training will be provided

Compensation & Benefits

• This position is salary exempt. xhyhwjd The pay range varies depending on skills, abilities, relevant experience, and length of service with the company
• Benefits for this position include Health, Dental, Vision, Disability, and Life Insurance coverage, optional participation in a Health Savings Account, voluntary Pet Insurance, 401k retirement match, paid time off and sick time.

Work Location: On-site in Grand Rapids, MI