Careers that make a difference! Freudenberg Medical designs and manufactures medical devices and components for clients worldwide.  We are focused on innovative processing technologies, lean manufacturing, waste reduction, and high quality product solutions for our Fortune 100 medical device customers.  Join our fast growing team with 11 manufacturing operations around the world. 

 

Ready to make a difference?

 

The Quality Engineer will work as a key cross-functional team member with the ENT product development team to bring to the market novel products and with regulatory to monitor the compliance of commercial medical device products.

Quality Engineer I - Class II Medical Devices
If you are a detailed-oriented professional who is passionate about making a difference in patients’ lives every day, were interested in hearing from you

Your tasks

  • Performs Quality Engineering tasks associated with Design & Development activities:
    • reviews/approves Design Control documentation (e.g. Design Verification, Process or component validation)
    • leads Test Method validation activities associated with Design Verification activities
    • represents Quality in NPD project team meetings & Design Reviews
    • prepares and releases Inspection Plans and Quality Control Inspection Criteria (QCICs)
    • supports qualification of purchased components
    • audits D&D activities to ensure compliance with procedures and standards
  • Leads or participates in Risk Management activities for new or legacy products (RMP, Risk Analysis, RMR)
  • Leads or participates in complaints analysis investigations and trend reporting for IHT products
  • Analyze internal and external quality product performance and address non-conformities.
  • Represent Quality engineering in Engineering Change Order process for IHT products
  • Leads elements of the Quality System as necessary
  • Participates in both Internal and/or External audits.

Our expectations

  • Bachelor’s Degree in engineering, Sciences or related discipline.
  • 2+ years of experience in a regulated industry (e.g., medical or pharma products).
  • Demonstrated experience with Quality System Tools (Control Plan, MSA, SPC, etc.).
  • Demonstrated experience with formal problem-solving methodologies, critical thinking and deductive skills.

Specific Skills and Knowledge

  • Statistics and statistical analysis software (e.g. Minitab)
  • Risk Management (ISO 14971)
  • Design Controls (21CFR 820)
  • Experience with GD&T and fixturing is preferred
  • ISO 13485

General Qualifications

  • Independence and self-direction coupled with a strong desire to work collaboratively as part of a high-performing team
  • Outstanding written and verbal communication skills
  • Keen ability to prioritize work and execute
  • Strong organizational skills; strong technical/computer skills

 

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.

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

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. #LI-FM2020

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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