Quality Assurance/Regulatory Affairs 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 DoReview 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! 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.
