Principal Quality Systems Specialist – Medical Device

Position: The Principal Quality System Specialist will be responsible for reviewing, improving, and maintaining the quality system, including the Quality Manual, procedures/processes, training, and complaint handling. This includes quality planning, training, vendor approval/monitoring, equipment calibration, complaint handling and trending, product recalls / advisory notices, corrective and preventive action systems, and internal and supplier quality audits.

Onsite Position – Located in the Greater Boston area.

Responsibilities:

• Drive continuous improvement.
• Continuously monitor and make recommendations to improve processes and procedures.
• Lead problem-solving teams through root cause investigations and failure analysis to implementation and final verification.
• Create relationships across the business that enable the sharing of knowledge, best practices, and solutions.
• Assist with implementing Quality Management-approved solutions to ensure compliance through effective, efficient, and sustainable QMS processes.
• Support, as needed, regulatory assurance, vigilance/incident reports & post-market surveillance.
• Support risk analysis activities associated with the QMS processes and drive a risk-based approach.
• Conduct Internal Audits of the Quality System and Supplier.
• Monitor supplier performance scorecard and management of supplier improvement activities.
• Prepare for and participate in audits by external organizations, such as FDA, ISO, etc.
• Lead and develop direct reports.

Requirements:

• Bachelor’s degree in science or engineering.
• 10-15 years of experience in Medical Device Quality Assurance.
• 5 years of hands-on management experience.
• Experience using tools such as CAPA, Six Sigma methodology, change control, Statistical Analysis, and Control Plans.
• Experience in stakeholder management and team leadership.
• Solid understanding of applicable regulations, including FDA 21 CFR Part 820, ISO 13485.
• Proven ability to support multiple projects and be results-oriented.
• Highly motivated and hands-on, consistently able to follow through on projects.
• Superior English language communication skills, written and verbal.
• Ability to interact effectively with all levels of personnel within the organization and external customers.
• Excellent organizational skills and attention to detail.
• Demonstrated ability to navigate through ambiguity and rapid growth and adapt to change.
• Understanding of Health Canada MDD’s, European MDR’s, MDSAP preferred.
• Quality Auditor Certification preferred.
• Six Sigma Experience / Certification.
• Knowledge of Medical Device start-ups is a plus.

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