NPD Quality Engineer

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? 

Plats

USA - Menomonie, WI

Arbetsplats

On-site
Sista ansökningsdag 2024-02-12 Plats: USA - Menomonie, WI

Imagine working for one of the leading contract manufacturers in the world. Be a part of Trelleborg Healthcare and Medical in Menomonie, Wisconsin!

As a premier manufacturer for life-saving medical components, Trelleborg Healthcare and Medical is a forward-thinking company. 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.

Seize this rare opportunity to be part of a healthcare and medical business unit that has been in business for over 100 years, all while enjoying the benefits of living in Western Wisconsin!

As a valued Trelleborg team member, you will enjoy:

  • Greater opportunity for impact;
  • Competitive compensation;
  • Outstanding benefits package: Health, Dental, Vision, STD, LTD, Life, 401k;
  • Generous paid time off;
  • Bonus potential

Trelleborg Healthcare and Medical is seeking a NPD Quality Engineer. In this role would be responsible to plan and coordinate quality assurance activities for medical device manufacturing through the design and development phases including validation for new product development. Collaborate with New Product Development (NPD) teams to support equipment qualification, software validation, test method development/validation, process development/validation (IQ/OQ/PQ), and other quality processes to ensure compliance with the company's Quality System and applicable external requirements and standards, including FDA, ISO 13485, and/or other regulatory agencies as applicable to medical device manufacturingWorking with internal and external customers to support creative approaches and solutions to problems.  

Quality Engineer Expectations:

  • In conjunction with the NPD team, plan, develop and execute equipment, software, test method, and/or process validation strategy 
  • Perform risk management by identifying, estimating, evaluating, controlling, and monitoring risk, utilizing risk tools such as Process Failure Modes and Effects Analysis (pFMEA) 
  • Author or approve protocols and reports for Equipment Qualification (IQ/EQ), Software validation (SV), Test Method Validation (TMV), Process validation (OQ/PQ) 
  • Review and evaluate specifications, drawings, quality agreements, customer documentation and other documents as necessary to support NPD projects 
  • Plan, coordinate, and oversee Test Method Development and Validation activities, initiate inspection plans for new/revised product 
  • Develop test methods or work with the Metrology team to recommend equipment, sampling plans, and measurement techniques for inspection specifications 
  • Perform measurement system analysis (MSA) Gage 1, Gage Repeatability and Reproducibility (GRR), Bias and Linearity, Resolution and Stability studies 
  • Perform statistical analysis of inspection data, process characterization, design of experiments (DOE) results, ANOVA, Capability Analysis 
  • Author and execute Quality Plans for Quality Management Systems and Organizational Objectives projects 
  • Initiate and perform root cause analysis, using statistical and capability analysis to solve problems 
  • Adhere to the company’s Quality System (QS), write, and approve QS documents 
  • Review and ensure compliance with QMS of all validation documents and records 
  • Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product 
  • Communicate with customers on clarification of specifications, completing customer documents, complaints, process changes, and other projects as needed 
  • Understand regulatory requirements (e.g. ISO13485, 9001, 14971, FDA 21 CFR 820, ITAR) 
  • Provide periodic work direction and assistance to QA inspectors, QA technicians and Quality Engineering Technicians 
  • Support other quality activities as necessary such as customer complaint (CC) and RMA system per procedures, corrective and preventive actions (CAPA), 
  • Support internal and external audits 
  • Other duties as assigned 
  •  
Required:
  • 4-year degree in quality, engineering or any related field

Desired:

  • ASQ Certified Quality Engineer 
  • Formal Six Sigma Yellow/ Green belt training 
  • Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable) 
  •  

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