QA Engineer II for Medical Devices

Arthrex GmbH; Pendleton (SC); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Annual Bonus

Free Onsite Medical Clinics

Free Onsite Lunch

Tuition Reimbursement Program

Matching 401(k) Retirement Plan

Job summary

Arthrex, Inc. is seeking an Engineer II for Quality Assurance on our Pendleton, SC manufacturing campus to support life cycle development of medical devices.

You will assist the Quality Manager and lead/participate in audits, CAPA, PFMEA, and validation activities. Responsibilities include reviewing design documentation, supplier quality, calibration/measurement systems, and leading continuous improvement initiatives while collaborating with cross-functional teams to ensure product quality and

Qualifications

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

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 PFMEAs and Risk Assessments.
• 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 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 (NCRs) as assigned.
• 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 CAPA Plans.
• Perform Engineering Studies and DOE as needed.

Skills

Design Controls

GD&T

DOE

Process Verification

Validation

Tools

Excel

Word

Minitab

SAP

Pilgrim QMS

Job description

Arthrex, Inc. is seeking an Engineer II for Quality Assurance on our Pendleton, SC manufacturing campus to support life cycle development of medical devices.

You will assist the Quality Manager and lead/participate in audits, CAPA, PFMEA, and validation activities. Responsibilities include reviewing design documentation, supplier quality, calibration/measurement systems, and leading continuous improvement initiatives while collaborating with cross-functional teams to ensure product quality and