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Quality Assurance Engineer II

Instrumentation Laboratory Company
Bedford, MA
Closing date
May 29, 2023

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.

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. This position works independently and with direct guidance from manager or more senior staff, 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 skills in analyzing information, reviewing technical reports, promoting process improvement, requirements development, risk management, product development and production controls.

Key Accountabilities

Essential Functions:
  • Participates in the generation and review of quality documents throughout the product lifecycle
  • Advises, 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
  • Works with manufacturing, R&D, Service, Sales & Marketing, and others outside the company (as needed) to recommend or prepare corrective / preventive actions (CAPA)
  • Reviews and approves change orders for product performance, process changes, labeling and marketing communications as required.
  • Other duties as assigned

Secondary Functions:
  • Participates in quality system improvement projects as required.

Budget managed (if applicable)
  • N/A

Internal Networking/Key relationships

To be determined based on department needs, to include interactions such as:
  • Works closely with other functions to generate compliant documents in alignment with quality procedures, applicable standards, regulations, and best practices.
  • Able to effectively communicate quality requirements to a broad population of constituents.
  • Ability to negotiate and influence others in establishing direction toward improved quality and enhanced compliance.

Skills & Capabilities:

The incumbent in this position will exhibit the following skills and capabilities:
  • Ability to read and interpret domestic and international quality/regulatory standards related to our products
  • Familiarity with IL products, technology, and manufacturing processes.
  • 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.

  • 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

Minimum Knowledge & Experience required for the position:
  • Education: Bachelor's degree or equivalent in engineering or science
  • Experience: A minimum of 2 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory or 0 years of experience with advanced degree
  • Additional Skills/Knowledge:
  • 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

International Mobility:
  • Required: No

Travel Requirements:
  • Approximately 10% of time

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

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

Job ID: 2022-5896

External Company URL:

Street: 180 Hartwell Road

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