Duties and Responsibilities (Key Deliverables):
1. Overall responsibility for managing and establishing the global process for medical device servicing and requirements related to Orthopedic Surgical Instruments.
2. Lead a team of local and global direct reports responsible for daily servicing activities including the receipt, evaluation, and disposition of surgical instrumentation.
3. Evaluate servicing data to identify and determine potential corrective actions to improve instrument design and reliability.
4. Monitors regulatory compliance with Exactech’s corporate Quality Management System by ensuring the Servicing Process meets all domestic and international requirements (e.g., FDA/ISO/EC/CMDR)
5. Assess and determine the appropriate resources to ensure internal and external customer requirements are adequately met.
6. Partner and promote effective collaboration with cross-functional business units that support the Servicing Process.
7. Lead a loyalty-based work culture, which empowers front-line employees to provide superior customer service while engaging employees to drive a continuous improvement mentality. Ensure that the highest standards of customer service are maintained.
8. Develop, implement, measure and meet quarterly and annual Quality goals and objectives.
9. Develop, maintain and ensure all Global Servicing related procedures are efficient, effective, and compliant.
10. Ensure environmental operating conditions are appropriate for products and in compliance with procedures to prevent any adverse impacts to the products.
11. Ensure all Servicing resources have the adequate tools and training needed to perform their job.
12. All Quality records are accurate, complete and in compliance with governing procedures.
13. Responsible for measurement, inspection equipment, and methodologies used for Surgical Instrumentation products.
14. Responsible for assisting in directing the Quality System activities for corrective and prevention actions, internal and third-party audits and customer complaint coordination and documentation.
15. Understand and comply with all department safety policies and procedures. Develop and maintain a clean and safe working environment to prevent accidents.
16. Conversant with the Medical Device Quality System and any relative Federal and International standards.
Education: Bachelor’s Degree in a related field from an accredited institution required; Master’s Degree preferred
• Minimum of 10 years’ experience, preferably in orthopedic or another medical device field.
• Working understanding and leadership capability to ensure Quality System requirements are implemented and measured for effectiveness.
• Minimum of 5-10 years prior QA Engineering management experience in a Medical Device Company.
• Experience in inspection specification development, statistical techniques, gage R&R, and G,D&T applications
• Prior audit experience with FDA and notified bodies.
Functional/Technical Knowledge, Skills and Abilities Required:
• Excellent verbal, written communication and leadership skills.
• Ability to work with all organizational functions.