Engineer II QA - Manufacturing

Hongkang Northamerica-posted 6 months ago
Mid Level
Corkscrew, FL
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Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for an Engineer II - QA for our manufacturing site in Ave Maria, FL. The ideal candidate will have a Bachelor's degree in Engineering and 2+ years experience in a Quality Control or Quality Assurance position in a Medical Device Company. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

  • 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.
  • Bachelor's degree in Engineering required.
  • 2 years experience in a Quality Control or Quality Assurance position in a 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.
  • Project management skills preferred.
  • 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)
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