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.

Senior Quality Assurance Engineer - Medical Devices
Previous experience identifying, implementing, and adhering to quality requirements for product development projects in the medical device industry

Your tasks

  • Work collaboratively with engineers and other personnel that are assigned to the product development project team.
  • Lead the creation, documentation, maintenance, and control of Quality System Plans and Risk Management Plans with the approval of both the internal and client project teams and in accordance with applicable corporate procedures.
  • Support the creation and maintenance of risk management documentation (e.g. FMEAs, hazard analyses, risk assessments, etc.). 
  • Assist in the identification and selection of outside suppliers and consultants as required.
  • Develop, maintain, execute, and control Component Validation Plans and external supplier qualifications during the product development lifecycle.
  • Create Q-sheets, Inspection Plans, and other component verification/validation documentation.  Facilitate the completion of component inspections and testing.
  • Initiate and lead the resolution of non-conformances / CAPAs.
  • Lead the creation and execution of test methods and test method validation plans in support of component, design, and process verification activities.
  • Analyze test data using statistical tools, perform in-depth interpretation of results, and generate detailed technical reports.
  • Provide support to project teams in the compliance of ISO13485, MDD / MDR, QSR, JPAL, and any other applicable standards or requirements.
  • Support and/or perform internal audits of the quality system and Design History Files (DHFs).
  • Create and maintain quality records for DHFs in accordance with FDA QSR and/or other regulatory requirements.
  • Support or lead design verification / validation activities including protocol and report writing.
  • Collaborate on process characterization, experimentation, optimization and qualifications.
  • Represent design assurance engineering interests in communications with clients and suppliers.
  • Incorporate the Critical Chain Project Management (CCPM) Work Norms into your daily work habits.
  • As appropriate, provide coaching and guidance regarding project tasks to other associates.

Our expectations

  • Bachelor’s degree in Engineering, Manufacturing or related field
  • A minimum of 6 years in medical device and/or healthcare product design and product development
  • Ability to identify and create unique and innovative designs.
  • Ability to formalize concepts for production fabrication of parts and assemblies.
  • Ability to create detail drawings for production fabrication of parts and assemblies.
  • Working knowledge of Geometric Dimensioning & Tolerance (GD&T), knowledge of materials and the characteristics of parts when fabricated from different materials (e.g. polymers and metals).
  • Knowledge of test method development to produce component parts.
  • Understanding of various manufacturing and production monitoring techniques.
  • Ability to use analytical techniques for design verification, problem and root cause analysis.
  • Working knowledge of both FDA and CE design controls
  • Ability to build and manage project schedules
  • Run project meetings
  • Experience with interacting and working with physicians and outside customers
  • Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) both to senior management, customers and associates
  • Ability to travel as required (10%)

 

Preferred Qualifications

  • MBA degree or the educational equivalent

Freudenberg Medical is a global partner for the design, development, and manufacture of innovative medical device technologies.  We offer the following services 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, Minnesota, Costa Rica, Europe and Asia. 

Freudenberg Medical manufactures minimally invasive, handheld and catheter-based devices out of our 93,000 square foot state-of-the-art facility, strategically and centrally located in Jeffersonville, Indiana. Freudenberg Medical’s culture is positive and team oriented. In our environment we like to have fun while helping others with our cutting edge medical devices. Our company is very driven to lead in the medical device industry to improve the quality of life of the patients we serve.

Freudenberg Medical is a local, innovative, high growth company with a collaborative, high performance work environment. We develop and manufacture minimally invasive, single use medical devices in the endoscopy, cardiovascular, neurovascular, and urology markets. The products we develop and manufacture are typically market disruptive and displace higher cost procedures.

Location: Jeffersonville, IN (near Louisville, KY)

We are looking for a Senior Quality Assurance Engineer who is:

  • Driven and focused on Value For Customers as defined in our Guiding Principles, ensuring that we deliver safe and effective catheter products in accordance with our Quality Policy.
  • Minimum 6 years of medical device experience, preferably in interventional devices and catheters
  • Project leadership experience with some project management skills
  • Ability to fill a variety of different roles within a project (test method validation, process, project planning/management)
  • Self-motivated and thrives in a fast –paced, cutting-edge environment with initiative to be proactive and seek out opportunities for improvement.

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 Minimally Invasive Solutions
Rachel Peterson ∙ Human Resources ∙ 2301 Centennial Blvd. ∙ 47130 Jeffersonville, IN ∙ www.freudenbergmedical.com/MIS
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