Engineer II - QA - SC

Arthrex GmbH; South Carolina; On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Annual Bonus

Onsite Medical Clinic

Onsite Lunch

Tuition Reimbursement

401(k) Matching

Paid Time Off

EAP

Job summary

Arthrex, Inc. is seeking an Engineer II for Quality Assurance on our Pendleton, SC campus.

You will support the Quality Manager in the lifecycle development and maintenance of Class I–III medical devices, working with cross-functional teams to ensure design quality and regulatory compliance. The role emphasizes design controls, PFMEAs, risk assessments, and process validation while coordinating audits and continuous improvement efforts.

Qualifications

• 2 years experience in a Quality Control or Quality Assurance position; medical device experience preferred.
• Technical knowledge in development methodologies including: Design Controls, GD&T, DOE, Process Verification and Validation.
• SPC (Statistical Process Control) knowledge.
• Experience with risk assessments, PFMEAs, control plans, and quality plans.
• Strong communication skills with technical and non-technical staff.

Responsibilities

• Review design drawings for tolerance, inspect-ability and quality of design issues.
• Work with suppliers to improve quality and assist in supplier process validations.
• Train QC Inspectors on inspection techniques and new equipment.
• Participate in internal and external quality audits as directed by QA Manager.
• Lead or support CAPA and nonconformance investigations and action plans.
• Lead or support environmental monitoring and DOE studies as needed.
• Create or review inspection method work instructions and test plans.
• Support Risk Management with cross-functional PFMEA and risk assessments.
• Perform routine nonconformance trending and quality reviews with management.

Skills

Quality Assurance

Design Controls

GD&T

DOE

Process Verification

Process Validation

SPC

Lean

Six Sigma

Problem Solving

Cross-functional Communication

Education

2 years experience in Quality Control/QA

Tools

Excel

Word

MiniTab

SAP

Pilgrim QMS

Agile/Design Lifecycle Software

Job description

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 Quality Assurance on our Pendleton, SC manufacturing campus. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective:

Responsible for supporting the Quality Manager with all quality related support for the life cycle development of Class I, II and III medical devices, including new product development and maintenance of released products.

Essential Duties and Responsibilities:

• Review design drawings for tolerance, inspect-ability and quality of design issues.
• Work with suppliers to improve quality, and assist, where necessary, in supplier process validations.
• Assist in the training of QC Inspectors on inspection techniques and the use of new equipment.
• 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.
• Support the AMI Engineering Change Management process by performing tasks as assigned.
• Lead or Support the internal manufacturing First Article Inspection process, review First Article Inspection Reports and samples (internal and/or supplier).
• Lead or Support equipment or process validation (IQ, OQ, PQ)
• Lead or support Metrology with design and development of inspection methods and gages.
• Create or review inspection method work instructions.
• Lead or support Metrology with Measurement System Analysis (Gage R&R) studies.
• Create Inspection Plans Supporting Receiving and In-Process Inspection.
• Investigate complaints as requested by the Complaints/Reliability team.
• Lead completion of Nonconformances (NCR’s) as assigned: material disposition plans, evaluations, and action plans.
• Perform routine Nonconformance and process trending and lead periodic Quality review meetings with the management team.
• Lead or Support Continuous Improvement projects.
• Lead or support the Environmental Monitoring program.
• Complete Root Cause Analysis Investigations and define Corrective/Preventive Action Plans (CAPA’s).
• Perform Engineering Studies and Design of Experiments (DOE) as needed.
• Other duties as assigned.

Education and Experience:

• 2 years experience in a Quality Control or Quality Assurance position required, medical device company preferred.

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

• Technical knowledge in development methodologies including: Design Controls, GD&T, DOE, Process Verification and Validation.
• SPC (Statistical Process Control) knowledge.
• Working knowledge of process improvement tools (i.e.: Lean - PDCA, Six Sigma - DMAIC) and problem solving (i.e.: Kepner Tregoe, Lean A3, 5 Whys) preferred.
• Working knowledge of risk assessments, PFMEAs, control plans, quality plans.
• Strong communication skills and ability to communicate effectively with technical and non-technical staff.

Machine, Tools, and/or Equipment Skills:

• Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), miniTab or similar statistical analysis software, SAP or similar inventory software, Agile or similar design lifecycle software, Pilgrim or similar QMS software.
• Knowledge of measurement and other inspection equipment.
• Manufacturing process knowledge
• 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 Time Off
• 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.