QA Specialist_QA Engineer (local candidates only)

Job Overview

Millstone is seeking an experienced Quality Assurance Specialist/Quality Engineer to join our growing medical device microbiology laboratory in Bloomfield, CT. The position will play a key role in maintaining the laboratory’s Quality Management System and ensuring compliance with applicable regulatory requirements, industry standards, and internal procedures. This is an independent role for a quality professional who is comfortable working in a regulated laboratory environment, exercising sound judgment, and taking ownership of assigned responsibilities from initiation through completion.

The successful candidate will work closely with laboratory and QA personnel to oversee and manage quality activities, including investigations, CAPAs, change controls, non-conforming materials, audits, equipment qualification, and controlled documentation. This individual will independently manage assigned activities, provide practical QA support to laboratory operations, and identify opportunities to strengthen processes and drive continuous improvement. The position will work closely with laboratory and QA leadership to address quality issues and maintain an effective Quality Management System and may provide occasional QA support to the Willington, CT production facility as needed.

RESPONSIBILITIES:

• Review and approve various investigations, including Out of Specification (OOS), Out of Tolerance (OOT), Non-conforming Laboratory Work, and Non-conforming Material investigations
• Review and approve equipment qualification and process validation protocols and reports
• Review controlled documents and records for compliance with applicable regulations, standards, and internal procedures
• Conduct and support quality investigations, including Corrective and Preventive Actions (CAPAs), customer complaints, and non-conformance investigations related to laboratory activities
• Own and manage assigned CAPAs and change controls, as assigned, though timely completion and effective implementation
• Perform QA disposition of non-conforming materials
• Create, revise, and implement controlled documents as needed to support CAPAs, change controls, and continuous improvement activities.
• Support internal, client, and regulatory audits, including audit preparation, hosting, participation as an internal auditor, response development, and follow-up activities.
• Participate in the integration, maintenance, and continuous improvement of Millstone’s Quality Management Systems
• Support the collection, analysis, and trending of quality metrics
• Provide QA support to the Willington, CT production site as business needs require
• Perform other quality-related duties as assigned

KNOWLEDGE & SKILLS

• Bachelor’s degree with 5 years relevant experience in Quality Assurance, Quality Engineering, or a related Quality function. Experience in a regulated pharmaceutical or medical device environment is preferred.
• Working knowledge of ISO 13485 and ISO 17025 requirements
• Working knowledge of applicable FDA/GMP requirements and quality systems within a regulated environment
• Experience with quality investigations, including CAPAs, non-conformances, complaints, and change controls.
• Experience supporting or participating in internal, customer, and/or regulatory audits.
• Knowledge of QC testing, particularly microbiological testing of medical devices, preferred.
• Excellent verbal and written English communication skills
• Strong proficiency with Microsoft Word, Excel, and PowerPoint
• Strong organizational skills and attention to detail, with the ability to manage multiple quality activities and meet established timelines.
• Ability to work with a team or independently with minimal supervision

Pay: $85,000.00 - $105,000.00 per year

Benefits:

• 401(k)
• Health insurance
• Paid time off

Work Location: In person

Salary : $85,000 - $105,000