Quality Engineer III

Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States

Country

United States

Shift

1st

About the Position

Introduction

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. Were passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

Position Summary The position is responsible to ensure that activities throughout the product lifecycle are compliant with procedures, standards, and regulations applicable to our products. The position works independently and with guidance from manager develops, applies, and implements methods, tools, and practices to achieve product quality goals and requirements in the areas of design, development, production, distribution, maintenance, and service.

This is a technically focused role requiring advanced skills in analyzing information, reviewing technical reports, promoting process improvement, requirements development, risk management, product development and production controls

Responsibilities

Key Accountabilities Essential Functions :

• Participates in the generation and review of quality documents throughout the product lifecycle
• Advises and directs teams , in coordination with management, regarding compliance to procedures, standards and regulations
• Ensures product quality meets requirements and documentation is complete prior to approval
• Participates on core teams supporting new product development or design changes
• On assigned projects, advises team regarding implementation of Design Control and Product Realization requirements for design, production, and distribution of IL products
• On new product development and or product performance investigations, provides guidance on tools and techniques available
• Provides input on product requirements, acceptance criteria, traceability, process monitoring, product evaluation, failure investigation and complaint analysis.
• Advises regarding application of sound statistical methods and quality tools in the evaluation and documentation of results related to design control, purchased part qualifications, V&V, risk analysis, production transfer, production, distribution and marketing of IL products.
• Provides guidance on compliance of software to procedures and standards including cyber security and privacy requirements
• Reviews and approves change orders for product performance, process changes, labeling and marketing communications as required.
• Other duties as assigned

Secondary Functions :

Internal Networking / Key relationships

To be determined based on department needs, to include interactions such as :

Qualifications

Skills & Capabilities :

The incumbent in this position will exhibit the following skills and capabilities :

Minimum Knowledge & Experience required for the position :

Additional Skills / Knowledge :

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individuals race, color, religion, gender, sexual orientation, gender identity / expression, national origin / ancestry, age, mental / physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@ for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

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