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Engineer II - QA at Strivector

Engineer II - QA

Strivector Naples, FL Full-Time
Strivector specializes in catering to your specific desired company culture and purpose-filled job needs.

We help our clients meet their fast-growing business, new and existing positions with talented individuals like you.

Strivector works alongside Fortune 500, mid-sized and Start-ups for full-time and contract positions; on our list of companies, we have Bank of America, Fannie Mae, Philips, Smith & Nephew, Arthrex.

Take your career up a few notches with this is a global medical device company and leader in orthopedics medical education

This is a Engineer II - QA position and requires someone who has 2 years experience in a Quality Control or Quality Assurance position in a Medical Device Company preferred.. As a Engineer II - QA your roles and responsibilities will include:
  • Client is a global medical device company and a leader in new product development and medical education in orthopedics. Client is actively searching for a QA Engineer II who 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, including 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 BetterTM.
    This is an onsite position in Ave Maria, Florida
  • 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.

Most importantly, you need to be a passionate Engineer II - QA who enjoys his work and is considered to be one of the best within your organization. The ideal Engineer II - QA would be someone with deep experience in many (if not all) of the following:
  • Education and Experience:
  • Bachelor s degree required preferably in an Engineering or Science discipline.
  • 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 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
We understand that even if you are a seasoned Engineer II - QA you may not have all the skills listed here. If you are a good at what you do and have a willingness to learn, lets talk.

Compensation: Based on Experience. One of the best in the industry
Minimum Education: Bachelor s degree required preferably in an Engineering or Science discipline.
Minimum Experience: 2 years experience in a Quality Control or Quality Assurance position in a Medical Device Company preferred.
Type of position: Full time Permanent Position with benefits
Telecommute: No
Location: Ave Maria, FL
Relocation accepted: Yes

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