Quality Assurance Supervisor/Manager

Come join Millstone Medical 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 MycoScience division (located in Willington, CT). MycoScience has over 30 years of expertise in medical device and pharmaceutical laboratory testing, environmental testing, and related regulatory support services. Mycoscience 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.

Millstone also engages in other activities, such as mechanical inspection and assembly, which are designed to meet the outsourcing requirements of medical device manufacturers seeking to reduce costs while maintaining high levels of quality, accuracy, and timeliness. We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO compliance.

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 the MycoScience Quality Management systems. The role is responsible for the coordination and implementation of on-site and desk/documentation customer audits of MycoScience and, related observations, Non-Conformances, CAPAs and communication of system results.

Core Competencies and Responsibilities include:

• Act as point of contact between MycoScience, and it’s customers on key compliance issues.
• Participate on Quality Management System (QMS) integration team.
• Leading and tracking in Millstone’s Mastercontrol electronic QMS as site administrator for MycoScience.
• Leading the internal audit program and compliance with regulatory requirements.
• Leading the CAPA program (CAPA, Complaints) and compliance with regulatory requirements. Maintain oversight on the day to day progress of quality issue records.
• Leading inter-departmental investigations with applicable departments for assessing and addressing potential quality issues.
• Review and approval of equipment and test method validation protocols and reports.
• Responsible for managing the Quality Assurance team.
• 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 13485 & 17025 compliance
• 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 MycoScience, please visit us online at https://mycoscience.com/.

ADDITIONAL INFORMATION:

Millstone Medical Outsourcing and MycoScience provides equal employment opportunity 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.

Job Type: Full-time

Pay: $70,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• Would you now or in the future require Visa sponsorship?

Work Location: In person

Salary : $70,000 - $100,000