Engineer II - QA Validation - SC at Arthrex Manufacturing, Inc. in Pendleton, South Carolina

Job Description:

Requisition ID: 60765 Title: Engineer II - QA Validation - SC 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 in orthopedics. We are currently seeking an Engineer II for QA Validation who is 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. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

1. Responsible for writing of protocols and conducting validations of special processes, including cleaning and passivation, electropolishing, molding, etc.


2. Responsible for reviewing and approving validations of special processes performed at all Arthrex facilities


3. Other duties as assigned

Education and Experience:

• Bachelor's degree in Engineering or Engineering technology required.


• 2 years of Process Validation work experience required, preferably within a Medical Device Company.

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 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.