Senior Engineer I - QA Validation

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Senior Quality Assurance Validation Engineer for our Pendleton, SC location. Five years of applicable experience is preferred. Bachelor’s degree in Engineering or Engineering Technology is essential for this position. Ideal candidates will have previous medical device experience. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective:

Responsible for supporting the AMI Validation Manager with all process validation related support for the life cycle development and manufacturing of Class I, II and III medical devices.

Essential Duties and Responsibilities:

• Responsible for writing protocols and reports for validations of special processes, including cleaning and passivation, electropolishing, molding, etc.
• Facilitate the execution of protocols by working closely with Engineering, Operations, Quality Control, and other manufacturing functions.
• Responsible for analysis of data generated from validations to evaluate process capability.
• Responsible for reviewing and approving validations of special processes performed at all Arthrex facilities
• Responsible for evaluating manufacturing changes for validation and/or revalidation requirements
• Encourages a continuous process improvement environment
• Recognizes and addresses process problems
• Provide daily direction and technical support to validation engineering staff, if applicable
• Interviews staff, oversees staff training, and responsible for staff development, if applicable
• Recommends proper staffing levels based on validation needs, if applicable
• Other duties as assigned

Education and Experience:

• Bachelor’s degree required in Engineering or Engineering Technology. 
• 5 years of Process Validation work experience preferred, within a Medical Device Company preferably. 

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Knowledge of testing equipment, statistical methods, control plans.
• Knowledge of cGMP and GDP requirements.

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), QAD or similar inventory software and MiniTab.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills

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

Language and Communication 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. 

Specific vision abilities required by this job include close vision using a microscope and light source.

Work Environment:

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.  The area that this job is performed in is a general office or open cubicle/workstation environment.  The noise level in the work environment is usually moderate.

Arthrex 2024 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 or protected veteran status.