Quality Assurance Engineer Tech — Night Shift (Medical Devices)

Arthrex GmbH; Northern (KY, SC); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

401(k) Retirement Plan

Annual Bonus

Tuition Reimbursement

Paid Time Off

EAP

Job summary

Arthrex, Inc. is seeking a Quality Assurance Engineer Tech for the Pendleton, SC location on a modified night shift: Mon–Thu 11:30 p.m.–10:00 a.m.

You will support the Engineering department through lifecycle development of medical devices, including new product development and maintenance of released products. The role entails root cause analysis, CAPA investigations, NCR management, and participation in cross-functional quality audits, with emphasis on risk assessment and metrology support.

Qualifications

• 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.

Responsibilities

• Complete Root Cause Analysis Investigations and assist or lead CAPA investigations.
• Facilitate completion of manufacturing and supplier NCRs: material disposition plans, evaluations, and action plans.
• Perform routine Nonconformance and process trending and lead quality review meetings.
• Investigate post-market manufacturing quality issues including complaint investigations and trending.
• Initiate and coordinate risk assessment activities in line with Quality System requirements.
• Support or lead Continuous Improvement projects.
• Review drawings for inspect-ability and create/ review inspection plans for manufacturing and receiving inspection.
• Support Metrology with inspection methods and gages; train QC Inspectors.
• Support Engineering Change Management by performing tasks as assigned.
• Lead First Article Inspection processes and review FAI Reports and samples.
• Conduct Engineering Studies and DOE as needed.
• Support equipment or process validation (IQ/OQ/PQ) and Metrology with Gage R&R studies.
• Collaborate with suppliers to improve quality and lead supplier RCA initiatives.
• Participate in internal and external quality audits.

Skills

Root Cause Analysis

CAPA investigations

NCR management

Quality Systems

Metrology support

Gage R&R

DOE

IQ/OQ/PQ

Risk Assessment

Supplier Quality

Education

AS or some college preferred

Experience in medical device manufacturing

Tools

SAP

NCR/CAPA software

Job description

Arthrex, Inc. is seeking a Quality Assurance Engineer Tech for the Pendleton, SC location on a modified night shift: Mon–Thu 11:30 p.m.–10:00 a.m.

You will support the Engineering department through lifecycle development of medical devices, including new product development and maintenance of released products. The role entails root cause analysis, CAPA investigations, NCR management, and participation in cross-functional quality audits, with emphasis on risk assessment and metrology support.