Quality Assurance/Regulatory Affairs Specialist II: Molecular Diagnostic Products
Maine Molecular Quality Controls, Inc
Saco, Maine
Maine Molecular Quality Controls, Inc is seeking a QA/RA Specialist II, to be based in the Saco, Maine office.
Requirements of the QA/RA Specialist II:
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- Bachelor of Science degree in Life Sciences and 5+ years of employment in a cGMP regulated facility and 2+ years of experience in Quality Assurance.
- Must be a nonsmoker due to product contamination prevention requirements.
- Vaccinations for Covid required, and a test within one week including results reported prior to starting work
- Excellent proof-reading skills are required.
- Knowledge of current GMP regulations is required.
- Strong skill in utilizing Microsoft Office software (Excel, Word, Outlook) is required.
- Technical writing skills required.
- Knowledge of ISO 13485 is required.
- Knowledge of In Vitro Diagnostic Regulation (IVDR) is required.
- Experience in laboratory medicine is highly preferred.
- Good communication skills, written and oral, with the ability to multi-task in a dynamic environment with changing priorities.
- Ability to meet challenging timelines, despite obstacles
- Willingness to learn and pitch in as part of a team
- Capable of rapidly developing sufficient expertise to function independently
Benefits of the Job:
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- Medical insurance, dental insurance
- 2 weeks of vacation
- 11 paid holidays, including 4 Flexible Days
- 7 paid sick days
- 401(k) retirement plan
- Profit-sharing plan
- Paid parental leave
- State-of-the-art facility located right next to the Eastern Trail
- Relaxed and challenging work environment
Responsibilities of the QA/RA Specialist II:
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- Reviews and approves all MMQCI Quality System documentation to ensure compliance with established procedures and regulatory compliance requirements, including, but not limited to, Master Batch Records, Standard Operating Procedures (SOPs), Change Orders, Material Review Notices (MRNs)and Corrective and Preventive Actions (CAPAs).
- Works closely with all departments to investigate MRNs and establish CAPAs addressing root cause.
- Reviews and approves validations of new equipment and processes.
- Assists or performs internal audits and supplier audits. Participates in, and may conduct, internal, customer, FDA, and ISO audits.
- Assembles Device Master Records for new products.
- Writes SOPs and oversees training documentation for all MMQCI employees.
- Maintains MMQCI’s ISO 13485 certification, prepares input into Technical Files for CE marking of MMQCI products and maintains international product registrations.
- Prepares and submits FDA pre-submissions, de novo requests, and 510(k) submissions for MMQCI’s Class II products and maintains appropriate FDA registrations.
- Interprets statutes, regulations, policies and guidance for MMQCI staff teams, communicating how these impact product development and Design Control, manufacturing, and/or marketing.
- Remains current on regulatory issues/trends.
- Works closely with the QA/ RA team and other MMQCI staff to review and approve product labeling changes, promotional literature and marketing materials, rework of non-conforming product, CAPA closures, Customer Complaint closures, and Medical Device Reports (MDR).
- Provides training or presentations to cross-functional groups on various regulatory topics.
MMQCI designs, develops, manufactures, and distributes quality control products to ensure the accuracy of medical laboratory diagnostic testing. MMQCI is passionate about improving patient care and offer a friendly community where employees work together to support their customers.
Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, ancestry, familial status, age, physical or mental disability, pregnancy, sexual orientation, gender identity, genetic information, veteran status, or any other characteristic protected by law.
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