The Freudenberg Group, a global technology group with 48,000 employees in some 60 countries, develops leading-edge technologies, and excellent products, solutions and services for more than 30 market segments. Freudenberg & Co. Kommanditgesellschaft, with its Headquarter in Weinheim, is the strategic parent company of the broadly diversified Group. Freudenberg Medical is a leading global manufacturer of components for medical devices, complex catheter systems for minimally-invasive surgery and total solutions for the biotech, healthcare and pharmaceutical industries.

Manufacturing Quality Engineer II
Medical device quality experience required in ISO13485 and ISO14971

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.

Freudenberg Medical is a global leader in medical contract manufacturing we offer the following services for medical device, pharmaceutical and IVD clients worldwide: product design and development, silicone and thermoplastic molding and extrusion, complex catheter systems, assembly, packaging, and engineering services.

For nearly 30 years, medical device and healthcare companies around the world have looked to Freudenberg Medical to make a difference as the custom manufacturer medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Freudenberg Medical maintains design and manufacturing centers in California, Indiana, Massachusetts, Costa Rica, Europe and Asia.

InHealth Technologies- In 1978, Drs. Blom and Singer pioneered the methods of tracheoesophageal voice restoration and valved silicone voice prostheses that for over the past 35 years have become the international standard for voice restoration, allowing thousands patients worldwide to regain their ability to speak. As a leading supplier of advanced voice restorations systems, our goal at InHealth is to help laryngectomies regain and preserve a vital part of their lives – their voice. InHealth is part of Freudenberg Medical.

Location: Carpinteria, CA

We are currently hiring for a Manufacturing Quality Engineer II who:

  • Is responsible to support manufacturing activities by developing standards and methods for inspections, testing and evaluation including trend and analyze internal as well as external quality product performance.  
  • Enjoys working independently and in a team environment where quality in manufacturing is key with a positive and can-do attitude to facilitate root cause analysis and implementation of corrective action for process related concerns. 
  • Hands-on with a thirst for critical thinking and logical problem solving with an interest in quality and manufacturing.
  • Knowledgeable with MSA and Quality Tools such as Gage RnR, pFMEAs, test methods and statistical techniques.
  • Self-motivated and thrives in a fast –paced, team-driven, “lean” systems environment, where every day brings new projects and challenges.

It’s an exciting time to work at Freudenberg Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Freudenberg Medical the employer of choice in this industry. We offer a competitive salary plus a full range of benefits including medical, dental and vision insurance, as well as 401K Match. Learn more about the InHealth Technologies products for the ENT marketplace at http://www.inhealth.com

Do you have any questions?

Freudenberg Medical - InHealth Technologies
Rachel Peterson ∙ Human Resources ∙ 1110 Mark Ave ∙ 93013 Carpinteria ∙ http://www.inhealth.com/Default.asp
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