Quality Assurance Engineer II
- Full-Time
- Torrance, CA
- Arthrex
- Posted 3 years ago – Accepting applications
Job Description
We are seeking a self-motivated Quality Assurance Engineer II for our Torrance, CA location to ensure the highest quality of products for the orthopedic trauma industry. The ideal candidate is collaborative and enjoys conducting root cause analysis. Experience in the medical device industry or ISO regulated environments preferred.
You will be joining a talented team passionate about quality and dedicated to making a worldwide impact by Helping Surgeons Treat Their Patients Better ™ !
Main Objective: 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.
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 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.
Education and Experience:
Bachelor’s degree required preferably in an Engineering or Science discipline.
3 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 (Staticstical 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.
Machine, Tools, and/or Equipment Skills:
Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), miniTab 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
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Nearest Major Market: Los Angeles
Apply to this Job
You will be joining a talented team passionate about quality and dedicated to making a worldwide impact by Helping Surgeons Treat Their Patients Better ™ !
Main Objective: 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.
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 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.
Education and Experience:
Bachelor’s degree required preferably in an Engineering or Science discipline.
3 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 (Staticstical 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.
Machine, Tools, and/or Equipment Skills:
Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), miniTab 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
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Nearest Major Market: Los Angeles