Engineer Tech - QA - SC

Arthrex - Pendleton, SC

Full-time - Entry Level

Pendleton, SC

Miscellaneous Manufacturing

About the position

The Quality Assurance Engineer Tech at Arthrex Manufacturing Inc. is responsible for supporting the Engineering department in the lifecycle development of medical devices. This includes new product development and maintenance of released products, ensuring compliance with quality standards and regulations.

Responsibilities

• Complete Root Cause Analysis Investigations and assist or lead Corrective/Preventive Action Plans (CAPA's) investigations.
• Facilitate completion of manufacturing and supplier related Nonconformances (NCR's) as assigned.
• Perform routine Nonconformance and process trending and lead periodic Quality review meetings with the management team.
• Investigate post market related manufacturing quality issues including complaint investigations and complaint trending.
• Initiate and coordinate risk assessment activities in accordance with Quality System requirements.
• Support, initiate or lead Continuous Improvement projects.
• Review drawings for inspect-ability, manufacturability, and quality of design issues.
• Support Metrology with design and development of inspection methods and gages.
• Support the AMI Engineering Change Management process by performing tasks as assigned.
• Support or Lead the internal manufacturing First Article Inspection process.
• Perform Engineering Studies and Design of Experiments (DOE) as needed.
• Support or Lead equipment or process validation (IQ, OQ, PQ).
• Support or Lead Metrology with Measurement System Analysis (Gage R&R) studies.
• Work with suppliers to improve quality and assist with supplier RCA and improvement initiatives.
• Participate in Internal and External quality audits as directed by the Quality Assurance Manager.
• Support Risk Management by leading or participating in cross-functional team pFMEA's and Risk Assessments.

Requirements

• 2 Years of post-graduation work experience with a High School diploma or GED equivalent.
• AS or some college preferred.
• Experience in medical device or manufacturing preferred.
• Experience with engineering specification documents and Quality standards preferred.

Nice-to-haves

• Proficiency in generating inspection plans.
• Proficiency in generating training methods on inspection best practices.
• Knowledge of standards, design, manufacturing, and processes.
• Ability to understand engineering specifications, drawings, and manufacturing processes.
• Knowledge and understanding NCR process and associated phases from initiation to closure.
• Ability to communicate effectively with technical and non-technical staff.
• Knowledge of MS Office, NCR/CAPA software and SAP.

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)