Quality Engineer I

Werfen•Bedford, MA

23h

About The Position

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA. Overview Position Summary: The position is an entry level position responsible to ensure that activities throughout the product lifecycle are complaint with procedures, standards, and regulations applicable to our products. This position, with direct guidance from manager or more senior staff, will work to achieve product quality goals and quality requirements in the areas of design, development, production, distribution, maintenance, and service. This is a technically focused role requiring skills in analyzing information, reviewing technical reports, promoting process improvement, requirements development, risk management, product development and production controls.

Requirements

Ability to read and interpret domestic and international quality/regulatory standards related to our products
Demonstrates judgement commensurate with experience regarding application of regulatory requirements to data review, reports, design changes, risk management, etc. to ensure compliance and achieving business objectives.
Demonstrated understanding of risk-based approach to processes and decisions.
Recognition of when to escalate issues to management or consult with more senior staff members.
Ability and willingness to learn about products, processes and procedures relevant to role
Attention to Detail : Ability to pay close attention to detail is required
Accuracy : Work is accurate and complete
Performance Standards : Demonstrated ability to meet department goals
Communication : Excellent written, verbal and presentation skills
Discretion: Acts with integrity in all situations and can maintain appropriate confidentiality
Multi-Tasking : Ability to manage multiple priorities, and support changing business needs
Collaboration : Ability to work within a team to bring best solutions to the team or customer
Independence : self-motivated-works under minimal supervision
Professionalism : Must demonstrate professionalism during all interactions within company, customer and third parties
Takes Initiative : Serves as a role model for “Quality First” by continuously improving on what matters most to customers
Problem Solving : Promptly and effectively handles issues and problems
Decision making: Makes decisions based on data and risk determination
Education : Bachelor's degree or higher in engineering or science
Experience: A minimum of 1 years of experience in a technical field or 0 years of experience with advanced degree
Duties necessitate basic knowledge of engineering and science theory and principles, including R&D, quality control, manufacturing, and design engineering.
Understanding of the application of technical principles and engineering problem solving to resolve complex issues.
Language: English

Responsibilities

Participates in the generation and review of quality documents throughout the product lifecycle
Ensures product quality meets requirements and documentation is complete prior to approval
Participates on core teams supporting new product development or design changes
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 Werfen 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
Participates in quality system improvement projects as required.