Arthrex ยท 5 hours ago
Supervisor - Validation Engineering
Pendleton, SC
Full-time
Onsite
Senior Level
7+ years expArthrex, Inc. is a global medical device company and a leader in new product development and medical education. They are seeking a Validation Supervisor to manage and maintain validation activities to ensure compliance and performance of manufacturing processes at their Pendleton, SC location.
Health CareMedical Device
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
Qualification
Required
Bachelor's degree or higher in an engineering or engineering technology discipline
At least 7 years of applicable experience
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
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
PC, proficient in Excel and database applications, statistical programs
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardizations exist
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements
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
Visual acuity necessary to do the job safely and effectively including close vision
Preferred
Previous supervisory experience is strongly preferred
3 years supervisory experience preferred
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)
Company
Arthrex
Arthrex is a global medical device company and leader in new product development and medical education in orthopedics.
10001+ employees
H1B Sponsorship
Arthrex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (22)
2023 (13)
2022 (13)
2021 (9)
2020 (12)
Funding
Current Stage
Late StageLeadership Team
Eric Butler
Sr. Director - Surgical Imaging & Integration
Kazu Miyahara
Senior Engineering Manager
Recent News
2025-12-24
Company data provided by crunchbase