What are the responsibilities and job description for the Quality Engineer position at Trelleborg Medical Solutions?

Trelleborg is a world leader in engineered polymer solutions that protect critical applications in demanding environments. Its innovative solutions accelerate performance for customers in a sustainable way. And we are where we are because our talents brought us here. In 2023, the Trelleborg Group had annual sales of approximately SEK 34 billion in around 40 countries. The Group comprises three business areas : Trelleborg Industrial Solutions, Trelleborg Medical Solutions and Trelleborg Sealing Solutions. The Trelleborg share has been listed on the Stock Exchange since 1964 and is listed on Nasdaq Stockholm, Large Cap. [www.trelleborg.com] (https : / / eur02.safelinks.protection.outlook.com / ?url=http : / / www.trelleborg.com / &data=05|01|maria.rifaut@trelleborg.com|3b757bb991bb411d827708dba3044535|0f86117777224f068db93384e5321a9f|0|0|638283010950261273|Unknown|TWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0=|3000|||&sdata=8TeIdPxJaN2pjtmrQi19WoTwOZDKNZxQKFP0DilDVgc=&reserved=0)

Imagine leveraging your quality expertise while working for one of the leading contract manufacturers in the world. Seize this rare opportunity to be part of a healthcare and medical business unit with the support and stability of an organization that has been in business for over 100 years.

Trelleborg Medical Solutions is seeking a Quality Engineer to join the Delano, MN team. 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. Working with internal and external customers supports, quality and continuous improvement using appropriate tools, project leadership.

As a valued team member with Trelleborg, you will enjoy :

Competitive compensation : Plus, bonus opportunities!
Generous benefits package : Includes health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more!
Clean work environment : Enjoy working in a very clean and climate-controlled environment every day!
Greater opportunity for impact : You will impact the production of life-saving devices.
Growth and advancement : Join a global company that loves to promote from within and allows for advancement.

Qualifications : Required :

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

7 years in a regulated manufacturing environment

Knowledge and experience with GMP / ISO Standards : ISO 9000 / 9001, ISO 13485, and FDA 21CFR 820 / 11 (4 / 210 / 211 as applicable)

Certified Six Sigma Yellow / Green

ASQ Certified Quality Engineer and / or Auditor

Class I, II, and / or III Medical device manufacturing experience

Desired

2 years in a manufacturing environment in a technical support role

ASQ Certified Quality Engineer

Formal Six Sigma Yellow / Green belt training

Responsibilities :

Quality Engineer Expectations :

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.

Salary range : Starting at $73k and up based on experience

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Salary : $73,000

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