Engineer II QA (Manufacturing)
ArthrexAbout the role
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™.
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.
Education and Experience:
- Bachelor’s degree in Engineering required.
- 2 years experience in a Quality Control or Quality Assurance position in a 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 Co
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