Manufacturing Quality Engineer II

Freudenberg Nonwovens   •  

Carpinteria, CA

Industry: Manufacturing

  •  

5 - 7 years

Posted 84 days ago

This job is no longer available.

Your tasks

  • Responsible to provide Customer and Engineering feedback in regards to MSA, Critical to Quality Characteristics (CTQ’s) and Acceptance Activities.
  • Lead Measurement System Analysis activities including Gage RnR, Test Method Validations, Test Procedures, etc. as part of the Design Transfer process.
  • Provides all planning necessary to ensure effective product acceptance. This includes, but is not limited to, inspection instructions, equipment and gage requirements, and sampling plans.
  • Close communication with Customers, Engineering, Operations, Inspectors and Suppliers on project matters, material issues, tooling and fixture design, process capability studies, and product quality issues for existing processes, products and related projects.
  • Support and develop validation protocols and reports (IQ/OQ/PQ) and provide objective evidence that equipment, processes, test methods and product meet requirements and are complaint with applicable regulations.
  • Lead effective quality control and associated risk management plans/reports - Risk Analysis.
  • Uses statistical tools (Minitab, etc) to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
  • Lead Quality Engineering on MRB review of nonconforming products; recommends disposition and corrective actions.
  • Represent Quality Engineering on CAPA and ECO (Engineering Change Order) develop and implement of any process changes and proper documentation of any such changes.
  • Leads complaint analysis investigations and trend reporting.
  • Participates in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
  • Lead standardization initiatives for Quality Engineering at the site level and partners with other Freudenberg Medical facilities.
  • Assesses the feasibility and soundness of proposed engineering evaluation tests, products, or equipment when necessary data are insufficient or confirmation by testing is advisable.
  • Execution of both Internal and/or External supplier and/or customer audits.
  • Review the visual production board on daily basis for issues related to productivity, downtime, equipment issues, and defects.
  • Support continuous improvement efforts to improve productivity through lean principles including but not limited to line layout and balancing, WIP reduction, material flow and equipment downtime.
  • Train inspectors and provide them with clear inspection instructions and standards of work to drive improvements in the quality of the products. Ensure actual inspector activities are reflected in appropriate documentation.
  • Leads elements of the Quality System as necessary.

Our expectations

  • BS Bachelor of Science Degree in Engineering or related field e.g. Microbiology, Biology, etc.
  • 5+ years’ experience in a regulated industry (e.g., medical products, nutritionals). Quality and Manufacturing areas are preferred.
  • Demonstrated experience with Quality System Tools (Control Plan, PFMEA, MSA, SPC, etc.) as well as GD&T and fixturing.
  • Demonstrated experience with formal problem-solving methodologies, critical thinking and deductive skills.
  • Ability to exercise judgment to determine methods, techniques and evaluation criteria for obtaining results.
  • Knowledge of clean room requirements (testing, monitoring and controlling).
  • Proficiency in the use of PC and programs, particularly Excel and Word.
  • Ability to communicate ideas and information clearly, effectively, and frequently (oral and written).
  • Able to prioritize and execute tasks in a timely manner with limited supervision.

Preferred Qualifications:

  • American Society for Quality CQE (Certified Quality Engineer)
  • Six Sigma knowledge and/or demonstrated practical statistics knowledge.
  • Experience with silicone material.