QA Manager Validation

Job Description
Requisition ID:
QA Manager Validation
Arthrex Manufacturing Inc
AMI East- INC- Ave Maria, FL
Main Objective: To manage and maintain validation activities to assure validations of traditional manufacturing and special processes at all Arthrex Manufacturing locations.
Essential Duties and Responsibilities:
Manage and direct Validation Engineers and personnel.
Manage and maintain traditional manufacturing process and special process validations by demonstrating compliance and performance including authoring and reviewing validations and product adoptions into existing validations.
Creation and maintenance of an Arthrex Manufacturing Master Validation Plan and validation matrix.
Manage equipment change control process and equipment/process risk assessment.
Assure compliance with Arthrex Master Validation Plan.
Perform testing and maintain documentation to support the facility validations.
Perform activities related to regulatory compliance and product/process evaluations.
Tie process/equipment validations with product quality, calibration, maintenance, and MOCs.
Integrate/document with maintenance to assure that preventive maintenance and unplanned maintenance returns equipment to a validated state.
Responsible for monitoring and training validation requirements at Arthrex Manufacturing facilities.
Tracks and trends non conformances related to validated processes.
Recognizes and addresses validated manufacturing process problems.
Incidental Duties:
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
B.S. Degree required.
10 years experience in a Quality Assurance position in a FDA regulated environment.
Minimum 5 years management experience in process validations in a FDA regulated manufacturing environment.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
In-depth knowledge of quality assurance techniques, practices, ISO and Regulatory (FDA) compliance
Ability to manage diverse department, and develop personnel in accordance with company objectives
Machine, Tools, and/or Equipment Skills:
PC, proficient in Excel and database applications, statistical programs.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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