Senior Director, Quality Operations, Service and Repair, Americas

Job Description

The Executive Director of Quality Operations, Service & Repair is responsible for building and directing a high-performing regional Quality Assurance organization, ensuring the quality management system is implemented, maintained, and continuously improved, safeguarding and improving product quality, maintaining regulatory compliance to applicable global regulations and standards, and instilling a culture of quality.

Establish strategic plans and drive tactical execution to improve, standardize, and optimize quality deliverables and execution of quality and compliance objectives across regional Field Service and Repair Centers, while maintaining alignment with global strategies and supporting business growth.

Define innovative solutions within the most complex and ambiguous areas of the business. Responsible for ensuring inspection readiness at all times, managing and facilitating regulatory audits and inspections, leading execution of commitments to regulators, and ensuring that quality and/or compliance issues are corrected in a timely manner.

The Executive Director of Quality Operations, Service & Repair will report to the VP of Quality Management, Service and Repair, oversee repair locations throughout the Americas region including US (San Jose, CA, Bartlett, TN), Canada, Brazil and Mexico as well as the Field Service for the region, and work collaboratively with other functions such as Operations, Service, Repair, Sales, Supply Chain, R&D/Design Assurance, Market Quality, and Regulatory Affairs to achieve organizational objectives.

Job Duties

• Proactively lead quality in support of Service and Repair activities across the Americas region, including oversight of regional 3rd party contractors, and work with operations to ensure right first-time quality and compliance with all applicable laws and regulations.
• Build, train and retain a competent quality organization. Develop and sustain a value driven, results-oriented culture and manage resources among competing departments, customers and projects.
• Implement, maintain, and continuously improve quality management systems that align with globally harmonized processes and ensure consistent, compliant and efficient execution.
• Anticipate and identify quality and compliance risks and proactively drive actions to mitigate. Ensure a sense of urgency commensurate with risk.
• Serves as the subject matter expert for quality, advising leadership and cross-functions on complex topics and ensuring compliant execution of work.
• Develop and implement regional annual Quality plans, departmental goals, and individual performance objectives in alignment with global plans.
• Identify compliance gaps and drive timely and effective actions to mitigate.
• In accordance with published service manuals and product risk documents, ensure implementation of effective service and repair work instructions, process controls, validation, calibration, maintenance, critical component evaluations, quality inspections, and return of product to customers.
• Ensure timely and thorough investigation and resolution of quality problems (nonconformance reports, customer complaints) and effective actions to correct and mitigate recurrence (CAPA). Lead complex investigations to identify causes of problems to safeguard patient safety and business continuity.
• Oversee controlled changes to products, processes, and systems.
• Ensure audit and inspection readiness and successful outcomes. Ensure any observations are adequately addressed and completed on time.
• Analyze product quality, compliance, and customer satisfaction data, identify trends, and collaborate with Design Assurance, Manufacturing Quality, Service & Repair and other functions to drive improvements.
• Prioritize programs to reduce product failures and remove roadblocks to ensure delivery of an integrated approach to Quality across the business.
• Engage in a positive manner with team members from all disciplines to ensure common goals are being met, lead initiatives to enhance the culture of quality and maintain a patient and customer focused quality mindset.

Job Qualifications

• BA/BS degree or equivalent in Engineering or Physical Science (with an advanced technical degree and MBA preferred).
• Minimum of 12 years Medical Device QA experience (with direct shop floor experience) in CGMP operations.
• Minimum of 5 years management experience, with responsibility for direct and indirect reports. Experience operating in a matrix environment strongly preferred.
• Experience with durable medical devices, and a strong understanding of installation and servicing requirements to ensure they continue to meet safety and performance specifications over their usable life.
• Effective Verbal and Written Communicator.
• Proactive approach to quality and compliance, with a focus on innovation and adaptation in a fast-paced environment.
• Demonstrated comprehensive expertise in the interpretation and application international regulations, guidance and standards governing CGMPs.
• Proven experience in designing, implementing, and improving quality systems and metrics.
• Strong ability to think and act globally, be fearless change agent while managing risks, develop future visions and engage broad audiences to drive transformation.
• Capable of presenting clear and insightful thoughts based in facts and data gain trust, build confidence and to influence key stakeholders across the business.
• Persistence to continuously improve, never settling for status quo, while keeping customer satisfaction and customer value central.
• Driving cultural change in a complex and diverse Olympus organization.
• Will work with global teams, availability will include working across global time zones. International and domestic travel up to 15% of the time.