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Quality Assurance (QA) Manager

Willington, CT

Come join Millstone Medical Testing and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work! Millstone Medical Outsourcing, a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry is recruiting at its Testing division location in Willington, CT. Millstone Medical Testing (formerly known as MycoScience) has over 30 years of expertise in medical device and pharmaceutical microbiological laboratory testing, environmental testing, and related regulatory support services. 

Millstone is an ISO 13485:2016 certified contract manufacturing organization operating out of an FDA-registered facility with a rigorous approach to quality that upholds Millstone’s commitment to operating under the highest quality standards. What's in it for you? A company committed to quality, growth, career pathing. At Millstone, we want you to be your best at work and at home. In addition to competitive compensation, we have designed our Total Rewards Benefits Program to support the physical and emotional well-being of our employees and their families. 

Total Rewards Benefits Program:

• Medical - Starting on the 1st day of employment

• Dental - Starting on the 1st day of employment

• Vision - Starting on the 1st day of employment

• Supplemental Benefits - Life, Disability, Critical Illness

• Paid Time Off

• Tuition Reimbursement

• Career Pathing

• 401(k) with match 

The Quality Assurance (QA) Manager will be responsible for managing Millstone Medical Testing Quality Management systems at all Millstone Medical Testing locations. The position, physically located out of the Connecticut facility (Bloomfield, CT), will support Millstone Medical Testing locations in Willington, CT and West Warwick, RI. The role is responsible for the coordination and implementation of on-site and desk/documentation customer audits of Millstone and, related observations, Non-Conformances, CAPAs and communication of system results. 

Core Competencies and Responsibilities include:

• Act as point of contact between Millstone and its customers on key compliance issues.

• Support ISO 17025 certification process and oversee subsequent ongoing compliance with ISO 17025.

• Lead auditor within the corporate internal audit program and ensuring site compliance with regulatory and internal audit program requirements.

• Lead the site CAPA program (CAPA, Complaints, NCMRs) and compliance with regulatory requirements. Maintain oversight on the day-to-day progress of quality non-conformance records. Maintain quality system metrics and lead site management review.

• Lead inter-departmental investigations with applicable departments for assessing and addressing potential quality issues.

• Primary Host for site customer and regulatory audits of Millstone Medical Testing facilities.

• Review and approval of equipment and test method validation protocols and reports.

• Management of the site(s) Quality Assurance team.

• Participate on Quality Management System (QMS) integration team and transition of QMS elements from paper based to electronic.

• Site administrator for Millstone’s Mastercontrol electronic QMS for Millstone Medical Testing locations.

• Other quality-related tasks as assigned. Knowledge & Skills:

• Bachelor's Degree

• 5+ years of relevant experience in Quality, Management, Engineering or Microbiology based testing

• Attention to detail with the ability to recognize and communicate potential issues

• Advanced math skills - basic statistics

• Advanced ability to create Excel, PowerPoint and Word documents

• Ability to write or re-write procedures, forms and master batch records

• Excellent organizational skills with the ability to provide supervision and leadership

• Excellent interpersonal skills

• Knowledge of standards and requirements related to FDA/GMP compliance

• Knowledge of standards and requirements related to ISO 17025 compliance required

• Knowledge of standards and requirements related to ISO 13485 compliance preferred

• Knowledge of medical device testing specifically microbiology based testing or medical device manufacturing

• ASQ or RABQSA certification preferred (i.e. CQE, CQA, Lead Auditor)

• ISO 13485 Lead Auditor certification or equivalent preferred

• ISO 17025 Lead Auditor certification or equivalent preferred 

To learn more about Millstone Medical and Millstone Medical Testing and to apply for this opportunity, please visit us online at https://millstonemedical.com/join-our-team/. 

ADDITIONAL INFORMATION

Millstone Medical Outsourcing and Millstone Medical Testing provide equal employment opportunities to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status, or any other status protected by applicable federal, state, or local law. All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.

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