Quality Engineer Technician-Medical Device

Trelleborg is a world leader in engineered polymer solutions for almost every industry on the planet. And we are where we are because our talents brought us here. By specializing in the polymer engineering that makes innovation and application possible, Trelleborg works closely with leading industry brands to accelerate their performance, drive their business forward—and along the way, shape the industry and progress that will benefit humankind in the exciting years ahead. Our people are Shaping Industry from the Inside. Why don´t you join us? 

Location

USA - Tustin, CA
Last application date 2022-12-24 Location: USA - Tustin, CA

Trelleborg Healthcare and Medical, Tustin, CA, is USA ISO 13485-2016 certified company, with all services performed in California. Minutes from some of the most beautiful beach cities in Orange County, the Tustin Facility is a contract manufacturer for the healthcare industry and specializes in Engineering Development, Manufacturing, Assembly, and Packaging of medical devices and combination products. If you'd like to be part of a dynamic, growing company that makes a difference in the lives of others - come join our team!

We are currently seeking a Quality Engineer Technician to join our Quality team. We offer competitive compensation, benefits, 401 k, and look forward to learning more about you.

In this role, you would partner with Quality Engineers in developing, troubleshooting, standardizing and improving new and existing production methods and procedures for new product release and legacy products. The ideal candidate would follow good manufacturing practices (GMP) and principles to help develop and maintain the quality system.

Responsibilities include:

  • Assists Engineers with the tasks related to the development and/or update of Risk Management FMEA and Hazard Analysis documentation
  • Supports Engineering group in development and performance of operational and process qualifications for customer manufacturing processes
  • Assists in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments
  • Performs data analysis, researching, compiling and analyzing information and assists in GR&R activities. Creates measurement system programs, when necessary
  • Communicates quality issues to Quality Engineers
  • Supports internal and external audit activities
  • Supports continuous improvement methods to help achieve company goals for a robust and effective system. 
  • Performs product and material testing, as needed.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPAs, Complaint/Customer Feedback, nonconforming material, etc. Executes corrections, corrective/preventive actions, as needed.
  • Provides statistical data/trending analysis on Complaint/Customer Feedback, nonconforming material, and other quality metrics.
  • Supports Quality System and Engineering groups with monitoring activities, as necessary. Performs analysis and presents to management.
  • Supports QA in the set-up of final product labeling including Unique Device Identification (UDI) barcoding, as applicable.
  • Assists with customer relations by gathering requests for information for Quality Systems group
  • Reviews and updates procedures, WI, forms, and etc, as needed.

Required Qualifications: 

  • 2 year degree in quality, manufacturing, engineering, or related equivalent experience

Desired:

  • 2+ years of regulated manufacturing experience.
  • Quality certification(s) (e.g. ASQ CQE, CQT, CQA, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
  • Other regulated manufacturing industry experience (e.g. Aerospace, Automotive, Defense, Pharmaceutical, etc.)
  • Knowledge and experience with GMP/ISO Standards.

TSS is an Equal Opportunity Employer and offers an excellent benefits package that includes:
• Life Insurance
• Health Insurance
• Vision Insurance
• Dental Insurance
• 401(k) plan

We welcome you to join our team during this exciting time!

Apply using this link: https://recruiting.ultipro.com/TRE1005TRLB/JobBoard/bf609905-b672-4f89-9d89-d81248503343/OpportunityDetail?opportunityId=f4bfd89b-1797-42bc-8e00-49685b8492ab

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