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.

 

Quality Engineer
Medical device quality system experience required in ISO13485 and ISO14971

Your tasks

  • Supports new product development and product maintenance through the application of Quality engineering skills for medical devices.
  • Handle multiple projects and tasks, from product inception through product launch and maintenance. 
  • Play an active role in the processes to ensure products meet quality standards consistent with internal quality policy.
  • Supports plant activities in process validation, process capability issues and customer issues, initiates corrective and preventive action, with an eye to increased capability, reduced inspection time/effort , customer satisfaction and supports Quality System implementation.
  • Helps establish manufacturing inspection, sampling and statistical process control methods and procedures to assure the quality of manufactured products.
  • Assures compliance to in-house and external specifications and standards, such as GMPs, GDPs, ANSI and ISO regulations.
  • Identifies and highlights any problem issues associated with quality. Provides input for solutions to problems identified.
  • Performs / leads root cause analysis to determine if corrective action is necessary. Assigns corrective action, if necessary, to the correct party. Responsible for reporting information on monthly basis. Interfaces with manufacturing for possible quality issues for new and existing product lines.
  • Assists with the investigation of root cause and determination of corrective and preventive actions relating to NCMRs and CAPAs. Responsible for corrective action effectiveness verification.
  • Works on continuous improvement projects from beginning to end. Characterizes the problem, identifies key process inputs, determines optimal operating window, implements controls to maintain output at desired level and quantifies the improvement in savings, avoidance, or value.
  • Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
  • Determines methods and procedures on new assignments, and may provide guidance to other associates.
  • Participate and support in safety and lean/continuous improvement initiatives.

Our expectations

  • Bachelor of Science degree in Engineering or related field
  • 2 - 5 years experience in quality engineering. 
  • 3 - 5 years engineering experience in the medical device industry.
  • Demonstrated competency in statistical process controls including control charts, data analysis, technical writing, continuous process improvement, including lean, six sigma, and validations.
  • Passion for manufacturing with an on-floor presence to advance product quality standards
  • Proficient with reading engineering drawings, written specifications, production documentation, using calibrated inspection equipment such as gauges, calipers, smart scope, multi-meters, manometers, pull test and other inspection equipment.
  • Certification in Quality Engineering, Biomedical Auditing, or equivalent
  • Demonstrated knowledge in Quality System Regulations/Good Manufacturing Practices.
  • Detail orientated, organizational skills and the ability to handle multiple projects.
  • 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 and Microsoft Project
  • Ability to communicate ideas and information clearly, effectively, and frequently (oral and written).
  • Flexibility to work different shifts as needed.
  • Ability to travel as required (minimal).

 

Preferred Qualifications:

  • Project management experience
  • Experience and knowledge with injection molding manufacturing operations.
  • Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and/or Regulatory Assurance Certification (RAC)
  • Lean/Six Sigma certification

Freudenberg Medical is a global leader in medical contract manufacturing; we offer the following services for 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.

Location: Baldwin Park, CA

We are currently hiring for a Quality Engineer who is:

  • Driven and proactive on ensuring a strong relationship with project leaders and operations in evaluating the Manufactured Product Quality data, manufacturing processes and responding to the customer's need
  • Able to demonstrate a sense of urgency and initiative on the manufacturing floor and performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions when necessary
  • 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
Rachel Peterson ∙ Human Resources ∙ 92 Blackburn Center ∙ 01931 Gloucester, MA ∙ www.freudenbergmedical.com
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