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 Bloomfield, 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 will be based out of thethe Bloomfield, CT facility , but will also 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. The ideal candidate will have in-depth knowledge of ISO 13485 and ISO 17025 standards, ensuring that our products and services meet the highest standards of quality and compliance. Key Responsibilities:Quality Management System (QMS):
- Maintain the Quality Management System in compliance with ISO 13485 and ISO 17025 standards.
- Ensure that all processes, documentation, and records adhere to the requirements of these standards.
- Regularly review and update quality policies, procedures, and manuals.
Audit and Compliance:
- Plan, coordinate, and execute internal and external audits in line with ISO 13485 and ISO 17025.
- Ensure compliance with relevant regulatory and customer requirements.
- Prepare for and participate in third-party audits and inspections, ensuring all findings are addressed promptly.
CAPA (Corrective and Preventive Action):
- Lead the CAPA program, including the identification, investigation, and resolution of quality issues.
- Implement effective corrective and preventive actions, and monitor their effectiveness.
- Drive continuous improvement initiatives based on CAPA findings and other quality data.
Document Control:
- Oversee the management of quality-related documentation, including the control of procedures, work instructions, forms, and records.
- Ensure proper change management processes are followed for all quality documents.
Supplier Quality Management:
- Manage the qualification and performance monitoring of suppliers and subcontractors.
- Conduct supplier audits to ensure compliance with quality standards and regulatory requirements.
Team Leadership:
- Lead and mentor the quality assurance team, providing guidance on quality issues and promoting a culture of continuous improvement.
- Provide training and support to staff on quality standards, procedures, and best practices.
Customer Interaction:
- Act as the primary point of contact for quality-related matters with customers.
- Address customer complaints and ensure effective resolution in a timely manner.
Qualifications:
- Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related field.
- Minimum of 5 years of experience in Quality, Management, Engineering or Microbiology based testing, preferably in the medical device or laboratory sectors.
- 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 preferred
- 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
- Strong experience with audit processes and CAPA management.
- Excellent problem-solving skills and attention to detail.
- Strong communication and leadership skills.
- Ability to work effectively in a team environment and collaborate with cross-functional teams.
To learn more about Millstone Medical and Millstone Medical Testing, please visit us online at 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.