Werfen North America · 7 hours ago
Quality Engineer I
Bedford, MA
Full-time
Onsite
Entry Level
$65K/yr - $80K/yr
1+ years expWerfen North America is a global developer and manufacturer of specialized diagnostic instruments and solutions for healthcare. They are seeking a Quality Engineer I to ensure compliance with quality standards throughout the product lifecycle, focusing on product quality goals and requirements in design, development, and production.
Health CareManufacturing
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
Qualification
Required
Bachelor's degree or higher in engineering or science
A minimum of 1 years of experience in a technical field or 0 years of experience with advanced degree
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
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
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
Benefits
Medical, dental, and vision insurance
401k plan retirement benefits with an employer match
Paid vacation and sick leave
Company
Werfen North America
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
Founded in 1959Bedford, Massachusetts, USA
1001-5000 employees
H1B Sponsorship
Werfen North America has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Giovanni Russi
Chief Operating Officer
Dominique J.
Human Resources Business Partner
Recent News
2025-07-19
2025-05-17
2025-04-04
Company data provided by crunchbase