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?

Quality Specialist - Process Monitoring and Material Release
Seeking Medical Device Quality Control Analysis Experience (Local Candidates ONLY)

Your tasks

  • Complete all incoming/raw material and component inspections, to include verifying all documentation, and properly identify/release those materials in ERP.
  • Perform inspection and verification of incoming materials, to include subcomponents and molded parts that have undergone off-site processing such as laser etch coatings, etc.
  • Supports in the review and disposition of raw material, in-process and finished goods to include (NCMR/sNCMR/Material Hold Quality Notifications), departmental training/cross-training,
  • Coordinates and monitors calibration requirements of test, measurement, and diagnostic equipment (TMDE).
  • Administers assignment of new TMDE asset numbers, calibration requirements, calibration frequencies, and their control.
  • Generates and investigates non-conformance reports (OOT’s – Out of Tolerance Reports) when TMDE is found to be out of calibration or missing calibration interval.
  • Isolates/quarantines OOT equipment, new equipment, equipment-pending calibration, and equipment received from calibration providers.
  • Verifies equipment calibrations against equipment calibration requirements.
  • Generates calibration health reports that feed into the Quality Management Review.
  • Notifies functional area managers for retrieval of equipment for calibration according to calibration schedule.
  • Schedules on-site calibration and pick-up by external calibration providers.
  • Keeps accurate records of calibration data and asset locations.
  • Writes, edits, and review work instructions and procedures for calibration.
  • Reviews and approves calibration requests for correctness (process/product specifications), including accuracy and precision requirements according to TMDE equipment entry form.
  • Monitor, document and verify environmental parameters regularly at frequencies identified by the procedure.
  • Compare environmental data against specifications. Investigate environmental non-conformance if out of tolerance environmental conditions are identified.
  • Coordinate with appropriate stakeholders to resolve environmental non-conformance along with environmental testing schedule.
  • Adhere to Good Manufacturing Practices and Good Documentation Practices as specified in Freudenberg Medical Quality System procedures.
  • Maintain accuracy and timeliness of test results and records.
  • Participate and support in lean/continuous improvement initiatives and safety initiatives.
  • Supports training and cross-training initiatives directly or through the development of specialized training instruction materials as related to the identification of defects, raw material inspection, subcomponent review, and molded parts analysis.

Our expectations

  • B.S. Degree or minimum of 2 years Quality Assurance/Quality Control experience preferred but not required.
  • Quality Control Analysis experience — Conducting tests and inspections of products, services, or processes to evaluate quality or performance.
  • Knowledge of quality inspection and disposition
  • Knowledge of Medical Device Quality System.
  • Working knowledge of IQMS and/or ERP system preferred.
  • Proficient in Microsoft Office Suite, Minitab, and other statistical software
  • Inspection marking systems.
  • Ability to communicate effectively (written & spoken) as required for job related communication throughout the organization.
  • Ability to work independently and as a member of a cross functional team.
  • Well organized, accurate and attentive to details.
  • Excellent communication and public relations abilities.
  • Strong typing and computer application skills.
  • Ability to assist and train others.

 

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: Baldwin Park, CA (Local Candidates ONLY)

We are currently hiring for a Quality Specialist - Process Monitoring and Material Release who is:

  • 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 - Baldwin Park, CA
Rechelle Mendez ∙ HR ∙ 5050 Rivergrade Road ∙ 91706 Baldwin Park, CA ∙ www.freudenbergmedical.com
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