Validation Engineer I
Artex Risk Solutions
full-time
Posted on:
Location Type: Office
Location: Pendleton • South Carolina • United States
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About the role
- 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
- Responsible for writing of protocols and conducting validations of special processes, including laser marking, passivation, laser welding, molding, etc.
- Responsible for reviewing and approving validations of special processes performed at all Arthrex facilities
- Facilitate the execution of protocols by working closely with Engineering, Operations, Quality Control, and other manufacturing functions
- Responsible for measuring validation parts and perform analysis of data generated from validations to evaluate process capability
Requirements
- Bachelor’s degree in Engineering or Engineering related technology required
- Experience in a Quality Control, Quality Assurance or Validation position in a Medical Device Company preferred
- Knowledge of testing equipment, statistical methods, control plans
- Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), QAD or similar inventory software
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)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
process validationprotocol writingdata analysisstatistical methodscontrol planslaser markingpassivationlaser weldingmoldingprocess capability
Soft Skills
collaborationcommunicationproblem-solvingattention to detailorganizational skills