Quality Engineering, Manufacturing

Requisition : 65858 Title: Quality Engineering, Manufacturing

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 Quality Assurance Engineers for our manufacturing facility in Ave Maria, FL. QA Engineers are 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.

Join our talented team at a growing 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.
• Other duties as assigned.

• Bachelor's degree in Engineering required
• Engineer I – Quality Assurance or Quality Control experience preferred
• Engineer II – 2 years of Quality Assurance or Quality Control experience required, preferably in medical device industry
• Engineer Senior – 5 years quality engineering experience in a highly regulated industry required

• 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.

• Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), mini
  
  Tab 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

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements. Prefer working knowledge and…