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?

Document Control Engineer I
(Local Candidates ONLY)

Your tasks

  • Review EOs to ensure no adverse impact to QMS and release approved changes
  • Manage Zrev table in SAP. Ensure alignment with paper-based DMRs and controlled distributions.
  • Support requests for controlled documents and records (e.g. Log records for archiving, Generate QMS record #s / Maintain Logs, Scan validation /verification reports, Fulfill check print requests)
  • Act as FMCS Site Records Administrator. Ensure QMS documents and records are readily available based on the needs of the organization (e.g. on-site filing, scanning for electronic distribution, prepping and logging off-site storage, coordinating pickup and retrieval from offsite storage)
  • Participate in departmental continuous improvement planning meetings & projects related to Document Control
  • Support any other Document Control activities as required

Our expectations

  • Knowledge of filing systems
  • At least 2 years of technical documentation experience in a medical device-manufacturing environment.
  • Proficient understanding of the requirements of cGDP/cGMP
  • General knowledge of the requirements of ISO 13485:2016
  • Proficient in Microsoft Word and Excel
  • General knowledge of SAP
  • Willingness to learn new skills and dedication to growth
  • Good verbal and written communication skills.
  • Excellent organizational skills and attention to detail
  • Good reasoning abilities and sound judgment
  • Capable of setting priorities and working under pressure
  • Ability to change priorities to meet customer requirements.

 

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

We are currently hiring for a Document Control Engineer I who:

  • Is responsible to execute change control processes for approved Engineering Orders and own Document Control System.  
  • Enjoys working independently and in a team environment where quality in manufacturing is key with a positive and can-do attitude. 
  • 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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