Engineer II - QA - SC

Arthrex; Pendleton (SC); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

FSA

Annual Bonus

Tuition Reimbursement

Parental Leave

Paid Time Off

Volunteer PTO

Job summary

Arthrex, Inc. is a global medical device company seeking an Engineer II for Quality Assurance on our Pendleton, SC campus. The role supports the Quality Manager in lifecycle development for Class I–III devices, including new product development and maintenance of released products.

Responsibilities include leading or supporting inspection methods, metrology, CAPA, risk assessments, audits, and continuous improvement projects to ensure product quality and compliance.

Qualifications

• Bachelor's degree in Engineering required.
• 2 years in Quality Control/Quality Assurance, medical device preferred.
• Strong knowledge of Design Controls, GD&T, DOE and process verification/validation.

Responsibilities

• Review design drawings for tolerance, inspect-ability and quality issues.
• Lead or participate in cross-functional PFMEA and risk assessments.
• Support internal/external quality audits and CAPA activities.
• Lead or support First Article Inspection and validation activities (IQ/OQ/PQ).
• Create or review inspection plans and metrology methods.
• Investigate complaints and lead NCRs and trending.

Skills

Quality Assurance

Design Controls

GD&T

DOE

Process Validation

Risk Management

Statistical Methods

Education

Bachelor's degree in Engineering

Tools

MINITAB

SAP

Pilgrim QMS

Job description

Requisition ID: 67747 Title:Engineer II - QA - 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 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™.

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

• Bachelor’s degree in Engineering required.
• 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.
• Project management skills preferred.

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

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.