Quality Manager

The Instrumentation Design & Development Quality Manager plays a crucial role in ensuring the quality compliance of instrumentation (hardware and software) and connectivity design & development. Reporting to the Senior Director Quality (Operations and Instrument Design & Development), this position is primarily based at the Maxim site while collaborating closely with key stakeholders across the Stirling Campus and Waltham sites. The incumbent will oversee all activities associated with instrumentation and connectivity design & development, including software, hardware, mechanical, electrical, connectivity, and associated testing requirements, ensuring adherence to Quality Management System (QMS) standards.

Responsibilities:

Quality Compliance:

• Support instrumentation departments to ensure Audit Ready Every Day and compliance with QMS.
• Identify gaps and Opportunities For Improvement (OFI), providing quality expertise, guidance, and training to address them.
• Support internal reviews and audits by providing required quality inputs.
• Utilize the Quality Management System to develop and execute processes for consistent, risk-based decision making.
• Monitor quality performance via Key Performance Indicators/metrics.

Project Management:

• Manage all QA activities associated with instrumentation design & development, change management, V&V, technical investigations, and departmental QA support.
• Interface with key stakeholders, acting as the primary contact for all QA activities.
• Provide data to facilitate effective planning of priorities.
• Provide regular project status updates to relevant teams and escalate any issues as needed.

People Management:

• Recruit, manage, coach, and develop the QA instrumentation team to achieve business goals.
• Plan and lead team activities to ensure compliance and timely completion of quality activities.
• Establish quality plans, schedules, and identify/implement improved ways of working within the QA team.

Design & Development Quality Assurance:

• Manage all design quality activities associated with instrumentation, ensuring compliance with QMS and regulatory standards.
• Maintain and update the Design History File and provide advice and support for regulatory submissions.

Change Management & Design Transfer:

• Provide quality expertise in change management and design transfer processes, ensuring compliance with procedures and regulatory requirements.

Quality Events & CAPA:

• Provide quality expertise and guidance in Quality Event & CAPA reports, ensuring compliance, timely feedback, and escalation of high-risk issues.

Process Improvements:

• Collaborate with quality personnel across sites to align on quality requirements and lead/support quality improvement projects.

Qualifications:

Essential Experience:

• Relevant experience in instrument design and development and manufacturing quality processes.
• Experience in medical device and/or in vitro diagnostics quality processes, including design review, change management, risk management, CAPA, and problem-solving tools.
• People management experience.
• Experience coordinating activities across multidisciplinary teams.
• Competent IT skills in Excel, PowerPoint, Word, and ability to adapt to new syste