Werfen · 3 months ago
Principal Quality Engineer
Bedford, MA
Full-time
Onsite
Lead/Staff
9+ years expWerfen is a company focused on ensuring product quality and compliance throughout the product lifecycle. The Principal Quality Engineer will lead quality initiatives, mentor staff, and ensure adherence to standards and regulations while promoting process improvement and risk management.
Health CareHospitalManufacturingMedical Device
Responsibilities
Participates in the generation and review of quality documents throughout the product lifecycle
Advises and directs teams 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
Defends relevant quality topics in audits and corrective actions to improve and maintain compliance of the QMS
Interprets regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies
On projects of significant scope, leads successful implementation of Design Control and Product Realization requirements for design, production and distribution of Werfen products
On new product development and or product performance investigations, provides guidance on most appropriate tools and techniques available
Provides input on product requirements, acceptance criteria, traceability, process monitoring, product evaluation, failure investigation and complaint analysis
Ensures 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
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
May manage and supervise the work of others
Leads cross-functional projects on technical and quality issues
Mentors and consults with other QE’s and functions regarding application of quality tools and principles
Identifies compliance gaps and takes appropriate corrective actions as needed
Supports internal and external audits
Leads quality system improvement projects as required
Qualification
Required
Bachelor's degree or equivalent in engineering or science
A minimum of 12 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory or 9 years of experience with an advanced degree
Deep knowledge of domestic and international quality/regulatory standards related to our products
In depth knowledge of quality management techniques (Lean, Six Sigma) and statistical techniques required to measure and confirm significant changes
Detailed working knowledge of Werfen products, technology and manufacturing processes including impact on customers and patient requirements
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
Ability to pay close attention to detail
Work is accurate and complete
Demonstrated ability to meet department goals
Excellent written, verbal and presentation skills
Acts with integrity in all situations and can maintain appropriate confidentiality
Ability to manage multiple priorities, and support changing business needs
Ability to work within a multi-function team to bring best solutions to the team or customer
Self-motivated-works under minimal supervision
Must demonstrate professionalism during all interactions within company, customer and third parties
Serves as a role model for 'Quality First' by continuously improving on what matters most to customers
Promptly and effectively handles issues and problems
Makes decisions based on data and risk determination
Preferred
ASQ Quality Engineering Certification - Desirable
LEAN/Six Sigma Certification - Desirable
Company
Werfen
Werfen is a developer, manufacturer and distributer of IVD testing solutions.
5001-10000 employees
H1B Sponsorship
Werfen 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
Dominique Petitgenet
Chief Operating Officer, Transfusion & Transplant
Ken Vogel, HCS
Human Resources Business Partner
Recent News
MarketScreener
2025-12-17
2025-12-08
Company data provided by crunchbase