Senior Quality Engineer-Medical Device
George Konik Associates, Inc. - Plymouth, MN

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SUMMARY

The Senior Quality Engineer works with cross functional project teams to lead quality activities for new product development and process improvement projects from concept through design, implementation, testing and documentation.

RESPONSIBILITIES
  • Analyze data, establish methods and implement process changes to reduce the frequency of non-conformances
  • Manage process control and validations to alleviate risk and ensure design requirements are met and documentation is complete
  • Assist Quality team in the creation of receiving inspection instructions associated with SCARs (Supplier Corrective Action Requests)
  • Participate in design reviews; communicating complaints and making recommendations for future designs
  • Support existing product/process improvement projects with suppliers
  • Review and approve document changes for nonconforming products. Ensure accuracy of required documentation (SPC data, inspection reports, control plans etc.)
  • Identify and implement inspection methods and equipment to reduce cost and improve productivity
  • Develop and implement CAPA (corrective and preventive action) plans
  • Formulate SOPs (Standard Operating Procedures) and product requirement specifications
  • Conduct quality audits and generate appropriate documentation.
  • Work with product development on new product designs and process improvements to ensure necessary process controls and documentation are in place to deliver quality products
  • Manage supplier process validation activities to ensure procedures are meeting quality standards.
  • Represent Quality team in project meetings and completing assigned tasks on time
  • Assist in preparing communications to regulatory reviewers and auditors
  • Bachelors Degree in Mechanical Engineering, Chemistry, Biology or similar discipline.
  • 7+ years of quality assurance experience in a medical device company. Background in biochemical engineering and/or materials science a plus.
  • Working knowledge of ISO 13485 and FDA requirements
  • Experience writing SOPs and product requirement specifications
  • ASQ Certified Quality Engineering certificate preferred
  • Knowledge of GD&T, inspection methods and FMEA
  • Knowledge of statistics, process control and process capability
  • Ability to understand material characteristics, tooling specifications and equipment
  • Demonstrated application of Six Sigma manufacturing concepts and Lean initiatives
  • Excellent time management skills and strong attention to detail
  • Excellent written and verbal communication skills
  • Able to work independently and efficiently to meet deadlines
  • Proficient in MS Office – Word, Excel etc.

George Konik Associates, Inc. (GKA) has been a leader in the technical staffing industry for more than 35 years, providing the fastest and easiest link between employees and employers. GKA has specialized in placing professional, qualified personnel in Minnesota and western Wisconsin businesses since its inception and maintains a strong commitment to customer service

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