Manufacturing Quality Engineer II

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 II

Your tasks

Ensure the manufacturing cell is aware of and meeting the customer’s quality needs and approval requirements. Provide clear product acceptance standards.
Support the manufacturing cell to create, monitor and investigate the effectiveness of the product line quality plan to identify, bracket, correct, and prevent defects or issues related to productivity, downtime and equipment issues.
Support the Manufacturing Engineer in efforts to ensure equipment and line is validated, qualified, and calibrated.
Train in-process 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.
Coordinate product bioburden and LAL testing and ensure lot is properly released .
Develop and maintain a relationship with the customer’s quality representative(s).
Improve Quality. Focus on product, process, and paperwork quality by incorporating the following activities:
- Lead and/or support activities for identification of root causes of non-conformances. If a CAPA is issued, facilitate the efforts to ensure the item is closed in an appropriate amount of time.
- Support Supplier Quality with supplier audit program and supplier changes.
- Train personnel on incoming inspection methods.
- Provide support and expertise in DOE, reliability strategy, and analytical problem-solving techniques.
- Lead client audits for assigned projects and support internal audit programs as an auditor.
Support efforts to smoothly transfer projects from product development into a long-term manufacturing.
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.

Our expectations

Bachelor of Science degree in Engineering or other technical degree.
3 - 7 years’ experience in quality engineering, manufacturing, or equivalent
Experienced in Medical Device Quality Systems (ISO 13485, ISO9000 and/or QSR)
Proficient with reading engineering drawings, written specifications, production documentation, using calibrated inspection equipment such as gauges, calipers, smart scope, multimeters, pull test and other inspection equipment.
Leadership ability and organizational skills including time management
Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work
Proficiency in the use of PC and programs, particularly Excel and Word to create procedures, work instructions, forms etc along with Minitab.
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written).
Execute tasks in a timely manner without direct supervision.
Drive to learn new skills and innovative processes to solve complex problems based on data and risk assessment.
Able to prioritize tasks.

Preferred Qualifications:

CQE, CQA (ratings)

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.

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: Louisville, KY (facility in Jeffersonville, IN)

We are currently hiring for a Manufacturing Quality Engineer who:

Driven and focused on ensuring quality for all manufacturing cells in operations.
Energetic and has a “Make it Happen” attitude to develop operators and technicians.
Striving to ensure Quality procedures are in place, accurate and followed.

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

Do you have any questions?

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