Medical Device Manufacturing, careers that make a difference!  Freudenberg Medical is a leading manufacturer of medical devices and components, complex catheter systems for minimally invasive surgery, and products for bio/pharma applications.  Join our fast growing team!

Ready to make a difference?

Manufacturing Quality Engineer I
Medical device quality experience in ISO13485 (LOCAL CANDIDATES ONLY)

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.
  • 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.
  • Provide clear product acceptance standards.
  • Responsible to update Quality Dashboards in the manufacturing area.
  • 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. 
  • Audit the Line’s production paperwork for accuracy; help drive the Line toward 100% first pass yield on DHR.
  • 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.
  • 1 - 3 years’ experience in a regulated industry (e.g., medical products, nutritionals). Quality and Manufacturing areas are preferred with experience interacting and supporting customers.
  • 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 including working with customers.
  • 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.
  • 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, part of the Freudenberg Group, is a global partner for the design, development and manufacture of innovative medical devices and components. With 11 manufacturing operations and more than 1,500 associates worldwide, Freudenberg Medical offers a wide range of manufacturing capabilities from high precision molding and extrusion to drug coatings, finished devices, and subassemblies for catheters and minimally invasive devices.

For over 30 years, medical device and healthcare companies have trust Freudenberg Medical to manufacture their custom components and devices. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Design and manufacturing operations are located in the United States (California, Indiana, Massachusetts, Minnesota), Germany, Ireland, Costa Rica, and China.

Location: Carpinteria, CA (Local Candidates Only at this time)

We are currently hiring for a Manufacturing Quality Engineer I 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.
  • 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.

Do you have any questions?

Freudenberg Medical - Carpinteria, CA
Rachel Peterson ∙ Human Resources ∙ 1110 Mark Avenue ∙ 93013 Carpinteria, CA ∙ www.freudenbergmedical.com
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