Sr. Engineer Quality Validation - Cleaning Validation

Description

The Sr Validation Engineer, QA provides leadership and cross-functional support in V&V development, planning and execution while maintaining corporate engineering and quality systems best practices, policies and procedures. The Sr Validation Engineer, QA is results oriented and has the knowledge and confidence in the areas of Quality Assurance and validation / verification (V&V).  This particular position has an emphasis on medical device cleaning validations.

Key Responsibilities

• Subject Matter Expert for medical device cleaning validation for sterile and reusable devices.
• Provide focused, technical, hands-on engineering assistance regarding V&V requirements of medical device processes, materials, equipment and methods including project management, process design, document generation (IQ, OQ, PQ, SOPs, WIs and ETSs), critical process parameter development, protocol execution and summary reports.

Projects include new product development projects, regulatory submissions, manufacturing changes, and manufacturing transfer

Skills Knowledge and Expertise

Education :

Experience :

Functional / Technical Knowledge, Skills and Abilities Required :

About Exactech

Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit www.exac.com for more information and connect with us on LinkedIn , VuMedi , YouTube , Twitter and Instagram .