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Manufacturing Quality Engineer II

Company: Freudenberg Group
Location: Carpinteria
Posted on: January 14, 2023

Job Description:

Freudenberg is a global technology group that strengthens its customers and society long-term through forward-looking innovations. Together with our partners, customers and the world of science, we develop leading-edge technologies, and excellent products, solutions and services for 40 market segments. The Freudenberg Group employs some 50,000 people in 60 countries worldwide and generates sales of over 10 billion euros.

At Freudenberg Medical, we make products that save and improve the lives of people every day, all around the world. We are a global provider for medical device design and manufacturing with more than 2,000 employees. Innovation is at the core of our company, and we are proud of our industry-leading quality, lean manufacturing, and focus on innovation in products and processing technologies. Freudenberg Medical is an exciting place to work with lots of opportunity to learn, develop, and grow your career. Come join us and together we can make a difference in the future of healthcare.

You support our team as

Manufacturing Quality Engineer II


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.
  • Focus on daily customer and process related issues to improve quality, on time delivery and process efficiencies.
  • 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.
  • Attends daily production meetings to provide communication and support to daily production requirements.
  • 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).
  • Conducts vendor qualification assessments and participates in supplier selection as necessary.
  • 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.
  • 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.
  • Pareto the defects and create improvement action plans
  • 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.
  • Support the Manufacturing Engineer in efforts to ensure equipment and line is validated, qualified, and calibrated.





    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, 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 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.

    • Preferred Qualifications:
    • American Society for Quality CQE (Certified Quality Engineer) preferred but not required
    • Experience with silicone is preferred.



Keywords: Freudenberg Group, Santa Barbara , Manufacturing Quality Engineer II, Engineering , Carpinteria, California

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