Job Description

Requisition ID: 64537 Title: Supervisor - Validation Engineering Division: Arthrex Manufacturing Inc (US02) Location: Pendleton, SC

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.

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.
• 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.

Education and Experience:

• 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
• 3 years supervisory experience preferred

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.

Reasoning Ability:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardizations exist. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Mathematical Skills:

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

Language Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.

Vision Requirements:

Visual acuity necessary to do the job safely and effectively including close vision

Work Environment:

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.