Quality Manager at Distron Corporation – North Attleborough, Massachusetts

The QA Manager is a detail oriented Quality Assurance (QA) professional responsible for ensuring that products, processes, and systems meet regulatory requirements and industry standards. The ideal candidate will have strong experience with quality management systems (QMS) and compliance with ISO standards such as ISO 13485 (medical devices), AS9100 (aerospace). This role plays a critical part in maintaining product integrity, regulatory compliance, and continuous improvement initiatives.

Responsibilities:

• Develop, implement, and maintain Quality Management Systems (QMS) in compliance with ISO standards (ISO 13485, AS9100, etc.)
• Ensure adherence to regulatory and customer requirements across all stages of production and development
• Conduct internal audits, supplier audits, and support external audits (certification and regulatory bodies)
• Manage CAPA (Corrective and Preventive Actions) processes, including root cause analysis and effectiveness checks
• Review and approve documentation such as SOPs, work instructions, and quality records
• Monitor quality metrics and drive continuous improvement initiatives
• Collaborate with cross-functional teams (engineering, manufacturing, regulatory, supply chain) to resolve quality issues
• Support risk management activities (e.g., FMEA, hazard analysis)
• Ensure proper document control and change management processes
• Train employees on quality standards, procedures, and compliance requirements
• Maintain and improve the QMS for compliance to (QMSR) Quality Management System Regulation
• Support product lifecycle activities including design controls, verification and validation (V&V), and design transfer
• Manage nonconformance (NCR) and deviation processes
• Participate in risk management activities in accordance with ISO 14971 (risk analysis, hazard evaluation, risk controls)
• Support supplier quality management, including qualification, audits, and performance monitoring
• Review and approve Device History Records (DHR), Device Master Records (DMR), and Design History Files (DHF)
• Monitor and analyze quality metrics to drive continuous improvement initiatives
• Perform other duties as assigned.

Required Skills/Abilities:

• Strong understanding of quality systems, metrics, and process governance within a manufacturing environment.
• Ability to analyze data, identify trends and translate insights into actionable recommendations.
• Proven ability to operate at both a strategic and operational level.
• Ability to maintain and improve the Quality Management System (QMS) in compliance with: ISO 13485, FDA Regulation and MDR (EU 2017/745) / IVDR (EU 2017/746) as applicable

Minimum Education and Experience Required:

• 5 - 10 years of related work experience within the manufacturing/production ideally within the electronics or medical device industries.
• Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related field
• Strong knowledge of:
• ISO 13485 (essential) and other ISO related standards
• FDA (QMSR)
• ISO 14971 (Risk Management)
• ISO 14001 (Environmental Management)
• IATF 16949 (Automotive QMS), etc
• MDR (EU 2017/745) / IVDR (EU 2017/746) as applicable
• Experience with design controls and validation processes
• Hands-on experience with CAPA, NCR, complaint handling, and audits
• Strong technical writing and documentation skills

Key Skills & Competencies

• Excellent problem-solving and root cause analysis skills
• Detail-oriented with strong documentation discipline
• Ability to work cross-functionally in a regulated environment
• Strong communication and interpersonal skills required.