Manager, Quality Operations Engineering
Department: Quality
Employment Type: Full Time
Location: Gainesville, FL
Reporting To: Director, Quality Management Systems
Description
Provide quality engineering leadership by inspiring individuals and teams while creating an environment of organizational excellence to deliver results.
Key Responsibilities
- Overall responsibility for managing Quality Engineering, Specialist support, managing key projects, and QA related aspects of the Quality Program. Apply appropriate resources and ensure project management is efficient and cost effective, while meeting internal and external customer requirements.
- Providing oversight for developing, maintaining, and ensuring compliance with Exactech’s corporate Quality System (including Exactech corporate and all subsidiaries); ensuring Quality System meets all domestic and international requirements (e.g., FDA/ISO/EC/CMDR)
- Collaborate with the E&D and Manufacturing project teams to ensure support from Quality is accurate and available to allow for successful on time project completion.
- Lead a loyalty-based work culture, which empowers front-line employees to provide superior customer service. Ensure that the highest standards of customer service are maintained.
- Develop, implement, measure and meet corporate and departmental goals.
- Develop, maintain and ensure all Quality Engineering related procedures are current and accurate.
- Ensure environmental operating conditions are appropriate for our products and in compliance with procedures to prevent any adverse impacts to the products.
- Develop, implement and document all Quality training.
- All Quality records are accurate, complete and in compliance prior to release of finished product.
- Responsible for product and process quality measurement and inspection equipment methodologies and processes for all implant and instrument products.
- Product quality records and product specification documents are accurate, maintained and organized along with being readily accessible.
- 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.
- Understand and comply with all department safety policies and procedures. Maintain a clean and safe working environment to prevent accidents.
- Actively participate in team meetings or on multi-skilled teams as necessary.
- Assist and support other employees, teams and sales personnel as necessary.
Skills Knowledge and Expertise
Education:- Bachelor’s Degree in Science from an accredited institution required; Master’s Degree preferred
Experience:
- Minimum of 7 years experience, preferably in orthopedic or other medical device field.
- Working understanding and leadership capability to ensure Quality System requirements are implemented and measured for effectiveness.
- Minimum of 0-5 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.
