Engineer II QA - Manufacturing

Arthrex

1d•Onsite

About The Position

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 Manufacturing for our manufacturing facility in Ave Maria, FL. The Engineer II QA is responsible for supporting the Quality Manager with all quality related support for the life cycle development of Class I, II, and III medical devices. This includes new product development and maintenance of released products. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Requirements

Bachelor’s degree in Engineering
2 years experience in a Quality Control/Quality Assurance position in a regulated industry.
Technical knowledge in development methodologies including: Design Controls, GD&T, DOE, Process Verification and Validation.
SPC (Statistical Process Control) knowledge.
Strong communication skills and ability to communicate effectively with technical and non-technical staff.

Nice To Haves

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.
Project management skills preferred.

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.