Supervisor - Validation Engineering

Arthrex

9d•Onsite

About The Position

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. Arthrex is actively seeking a Validation Supervisor to support manufacturing processes at our growing Pendleton, SC location. Successful candidates must possess a Bachelor's degree or higher in an engineering or engineering technology discipline with at least 7 years of applicable experience. Previous supervisory experience is strongly preferred. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™. Main Objective: To manage and maintain validation activities to assure validations of traditional manufacturing and special processes at all Arthrex Manufacturing locations.

Requirements

B.S. Degree in Engineering discipline required
7 years experience in a Quality Assurance position in an FDA or similar regulated environment requiring validation activities
3 years leadership experience in process validations in a FDA or similar regulated manufacturing environment requiring validation activities

Nice To Haves

3 years supervisory experience preferred
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

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.
Provides input to or may create and maintain Arthrex Manufacturing Master Validation Plans and validation matrix. Ensures compliance with these plans.
Evaluates equipment for potential validation needs as part of the equipment purchase / equipment change process.
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 ensure that preventive maintenance and unplanned maintenance returns equipment to a validated state.
Collaborate with Global Process owner to develop and deliver validation training at Arthrex Manufacturing facilities.
May track and trend non conformances related to validated processes.
Recognizes and addresses validated manufacturing process problems.
Ensure compliance within functional area and support the compliance objectives of the organization as a whole.
May serve as site SME representing validation during internal, corporate and external audits.