Job Description

Trelleborg Medical Solutions partners with the world’s leading medical device and biopharmaceutical companies, collaborating from concept to commercialization to bring to market impactful solutions that improve patient quality of life. It leverages decades of design and manufacturing experience, in-depth knowledge of polymer materials and a deep understanding of customer applications and end-use environments to deliver pioneering, engineered solutions for transformative health technologies. Utilizing its global quality system and engineering and manufacturing network, the company is a production partner of choice for medical device and biopharmaceutical companies.

About the Role

The Senior NPD Quality Engineer will be responsible for planning, developing, and executing quality assurance activities throughout the product development lifecycle. The NPD Quality Engineer is 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 manufacturing. Working with internal and external customers to support creative approaches and solutions to problems.

Responsibilities:

• 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.

Qualifications

• 4 year degree in quality, engineering or any related field.
• 5+ years in a manufacturing environment in a technical support role.
• Knowledge and experience with GMP/ISO Standards.

Required Skills

• Ability to read, write, speak and understand the English language (with a translator, if necessary).
• Ability to communicate clearly by conveying and receiving ideas, information and direction effectively.
• Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately.
• Demonstrated competence using Microsoft Office, Project, Access and JMP.
• Comprehensive understanding of applicable Work Instructions, SOPs, and ISO standards.
• Working knowledge of statistical methods associated with six sigma and quality control.
• Able to perform math functions.
• Effective project leader.
• Experience with lean manufacturing principles and their implementation.
• Good hand/eye coordination and depth perception.
• Good manual dexterity.
• Correctable normal reading distance vision.

Preferred Skills

• Certified Six Sigma Yellow/Green.
• ASQ Certified Quality Engineer and/or Auditor.
• Class I, II, and/or III Medical device manufacturing experience.

Pay range and compensation package

Salary range: $90,000-115,000/year

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.

Equal Opportunity Statement

Trelleborg is committed to diversity and inclusivity in the workplace.

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