Manufacturing Quality Engineer II

1 day ago

Carpinteria, United States Freudenberg Group Full time
Working at Freudenberg: We will wow your world

Responsibilities:

  • 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.
  • Lead standardization initiatives for Quality Engineering at the site level and partners with other Freudenberg Medical facilities.
  • 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.
  • 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.
  • 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.
  • 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.
Qualifications:
  • 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, nutritional's). 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 and deductive skills.
  • Six Sigma knowledge and/or demonstrated practical statistics knowledge is a plus.
  • Ability to exercise judgment to determine methods, techniques and evaluation criteria for obtaining results.
  • Proficiency in the use of PC and programs, particularly Excel and Word (or equivalents if changed by the Company).
  • Ability to communicate ideas and information clearly, effectively, and frequently (oral and written).
  • Execute tasks in a timely manner with limited supervision.
  • Able to prioritize tasks.
  • American Society for Quality CQE (Certified Quality Engineer) preferred but not required.
  • Experience with silicone is preferred.


The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

Freudenberg Medical LLC

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