Quality Systems Specialist-Paso Robles, CA

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.

Location

Paso Robles/CA

 

Trelleborg Healthcare and Medical is headquartered in Paso Robles in an 110,000 square foot state of the art cleanroom manufacturing facility. We are a premier manufacturer for life-saving medical components, and our company is a very dynamic, forward thinking business. We have been active in our lean manufacturing journey for many years and are advancing towards making our business a showcase of excellence in the medical industry. Visit us at www.trelleborg.com

Trelleborg is an ISO 13485 certified manufacturer of custom silicone components and parts for the medical device industry. Our specialties include silicone extrusion, molding, sheeting and closed cell sponge/foam. 

Trelleborg is an Equal Opportunity Employer and offers an excellent benefits package that includes:

  • Life Insurance
  • Medical Insurance
  • Vision Insurance
  • Dental Insurance
  • 401(k) plan
  • Generous PTO plan
  • 11 paid holidays

We currently have an opening for a Quality Systems Specialist. In this role, the Quality Systems Specialist is focused on the maintenance of the Quality Management System (QMS) to ensure compliance with regulatory, quality, company policies and manufacturing requirements.  

Some of the essential functions include:

  • Supports all aspects of the internal audit program, ISO notified body audits, customer audits and FDA inspections, including but not limited to: 
  • Serve as an auditor for internal audits 
  • Create and maintain internal audit schedule 
  • Audit controlled document files in preparation for regulatory inspections and provides support during regulatory inspections and client audits 
  • Initiate and execute audits, including developing and documenting the audit plan, leading the audit, generating the audit report, and tracking subsequent actions with the team 
  • Provide support during external audits including scheduling, hosting, preparing audit responses 
  • Work with subject matter experts to ensure audit record content is accurate, well documented, and meets the requirement of the process 
  • Develops metrics and performs trend analysis of key QS areas such internal and external audit findings, CAPAs, Nonconforming material, training, deviations, etc. to identify areas for improvement. Escalates trends to an appropriate quality system such as CAPA or CI; presents analysis to management committees. 
  • Supports maintenance of the CAPA program. 
  • Can act as a CAPA Owner, driving necessary investigation, correction, and corrective/preventive actions. 
  • Ensure and track all Internal and External audit findings are entered into the CAPA system, assigned to the appropriate personnel, and are completed in accordance to the CAPA procedures, within specified time periods 
  • Approve corrective action plans and verify effective and timely implementation of corrective actions for audit nonconformities 
  • Supports and coordinates activities related to nonconforming material, Complaint/Customer Feedback, Deviations, RMA, and CAPA processes. 
  • Manages review of documents to ensure ISO/FDA compliance of controlled documents lifecycle including annual review management 

Required: 

  • 4 year degree in quality, regulatory, science or engineering; OR certificate in regulatory science or medical product development; OR or equivalent combination of  education and experience 
  • 3 years of quality/regulatory experience in the medical device or related industry. 
  • 1 year experience conducting investigations and root cause analysis for complex/advanced issues. 

Desired: 

  • ISO13485:2016 and/or ISO9001:2015 Auditor Certification 
  • Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable). 

PLEASE NOTE:  To be considered, you must apply using this link: 

https://recruiting.ultipro.com/TRE1005TRLB/JobBoard/e29d2cd1-2e41-4fb7-99cf-4974ca632ddb/Opportunity/OpportunityDetail?opportunityId=1fc574c7-3787-4f21-b185-945bd9275d01