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?

Trelleborg Healthcare and Medical, Tustin 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 with a Pharma and/or Manufacturing background to join our Quality team. At TSS, we offer competitive compensation and a robust benefit package for benefit-eligible employees that include medical, dental, vision, an employer-matching 401 k plan, bonus potential,12 paid Holidays, 3 weeks of PTO, etc. We look forward to learning more about you and sharing details on our work culture and what sets us apart from other employers.

In this role, you would be responsible for the development and administration of a Quality System compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test, and label control operations. You would work with both internal and external customers supporting, quality, and continuous improvement using appropriate tools, and project leadership.

Responsibilities include:

• Supports internal audit program as necessary.
• Supports customer complaint (CC) and RMA system per procedures. Performs investigations, supports determination of the disposition of returned goods, determines re-inspection requirements, determines corrective and preventive actions (CAPA), issues complaint reports, supports completion of customer CAPAs, and approves to close. Looks for trends to determine actions to decrease number of CCs
• Maintains Non-Conforming (NC) system per procedures. Performs investigations, participates in MRB (Material Review Board) activities, supports determination of the disposition, determines re-inspection requirement, supports determination of corrections/corrective actions and approves to close. Looks for trends to decrease number of NCs and provide feedback to management
• Maintains corrective and preventive action (CAPA) system per procedures. Initiates and performs root cause analysis. Uses statistical and capability analysis to solve problems. Implements and verifies CAPAs
• Performs trend analysis of CAPA, NCM, Complaint/Customer Feedback, Risk Management activities, Audits, etc. and presents periodic reports for management review. Assesses Design and any associated activities for manufacturability.
• Adheres to the company’s Quality System (QS), writes and approves QS documents
• Authors and executes Quality Plans for Quality Management Systems and Organizational Objectives projects.
• Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product quality.
• Communicates with customers on complaints, process changes, clarification of specifications, completing customer documents, and other projects as needed
• Conducts studies including Gauge R&R’s to develop inspection methods and test equipment. Creates measurement system programs, when necessary.
• Establishes inspections and sampling procedures to ensure the control of quality at the most economical costs
• Creates, reviews and approves Equipment Qualifications, Process, Cleaning, and Software Validation, pFMEA and other documentation as necessary.
• Participates in customer and ISO audits.

Required Qualifications:

• 4-year degree in quality, engineering, or any related field

Desired:

• 2+ years in a pharma and/or manufacturing environment in a technical support role
• ASQ Certified Quality Engineer

• Formal Six Sigma Yellow/ Green belt training

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

• Life Insurance
• Health Insurance
• Vision Insurance
• Dental Insurance
• Bonus Potential
• Matching 401(k) plan
• Start with 3 weeks of PTO
• 12 Paid Holidays
• Electric Car Charging Stations

We welcome you to join our global organization and Tustin team during this exciting time!

Apply using this link: https://recruiting.ultipro.com/TRE1005TRLB/JobBoard/bf609905-b672-4f89-9d89-d81248503343/OpportunityDetail?opportunityId=e4f6bb71-59f3-46a3-bc32-cdc7b23c2f11