Ensure Quality & Compliance as Our Next QA/RA Specialist!

The Quality Assurance/Regulatory Affairs Specialist plays a key role in supporting quality assurance activities and ensuring compliance with applicable regulatory requirements. Reporting to the Manager of QA/RA, this position is responsible for maintaining policies and managing procedures that support MMQCI’s Quality System in alignment with ISO 13485 standards.

The ideal candidate brings experience working within an ISO 13485-regulated environment and is comfortable supporting and maintaining quality systems. This role offers the opportunity to quickly build expertise while working in a collaborative environment.

What You Will Get to Do

Review and approve all Quality Management System documentation (i.e. batch records and QC testing) to ensure compliance with QMS certifications and investigations

Collaborate with departments to investigate Material Review Notifications and develop Corrective and Preventive Action plans

Independently reviews and authorizes process and equipment validations

Performs or assists with audits, including internal, customer, and regulatory audits

Maintains MMQCI’s ISO 13485 certification

Writes SOPs and trains key personnel as needed to support all departments

May be called on to assist others and perform additional tasks as assigned

Required Skills & Experience

Bachelor’s degree in Life Sciences with 5+ years’ experience in a cGMP-regulated environment, including at least 2 years in Quality Assurance

Knowledge of current GMP regulations, ISO 13485, and In Vitro Diagnostic Regulation (IVDR) is preferred

Strong written and verbal communication skills; proficient in Microsoft Suite

Excellent proofreading skills with strong attention to detail

Ability to manage multiple priorities in a fast-paced, changing environment and meet challenging deadlines

Strong work ethic, team-oriented mindset, and willingness to learn

Ability to communicate clearly and constructively

Must be able to lift up to 30 lbs

Why You’ll Love Working Here  

Opportunity to make a meaningful impact within a growing diagnostic company
Collaborative, mission-driven team environment 
Competitive compensation and benefits

Benefits We Offer

Medical, dental, and vision insurance
401(k) retirement savings plan
Company profit sharing program
Paid time off, including vacation, holidays, and sick leave
Paid Parental Leave Program

The pay range for this position is $27.88 to $53.85/hour

Get to know the MMQCI team!
https://www.mmqci.com/about/employee-spotlight/employee-spotlight.html

Maine Molecular Quality Controls, Inc. (MMQCI) designs, develops, manufactures, and sells unique quality control products used by hospital laboratories and manufacturers to monitor the accuracy of tests for genetic, oncologic, and infectious diseases. MMQCI has proprietary technologies to stabilize DNA and RNA for use as quality controls and continues to pursue the discovery of novel techniques useful for the development of new quality control products.

MMQCI is conveniently located in beautiful southern coastal Maine, minutes from the Maine Turnpike, Portland International Jetport, and less than 2 hours from Boston. Close by are fabulous Portland restaurants, sandy beaches, and a plentiful supply of Maine lobsters! Many terrific outdoor activities are easily accessible including hiking, biking, kayaking, fishing, skiing and snowshoeing. We’re in a state-of-the-art facility, located in Saco, right next to the Eastern Trail. Come join us!

Interested in joining our team? Please submit both a resume and cover letter with your application for consideration.

Quality Assurance and Regulatory Affairs Specialist

MMQCI

Compensation Overview