Principal Quality Engineer

Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States

Country

United States

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. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

The position is responsible to ensure that activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our products. This position provides project/program level leadership, independently 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. Provides mentoring and consultation to QE staff on relevant issues.

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. The position expected to lead by example in alignment with the company values to achieve objectives.

• 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
• Other duties as assigned

• Identifies compliance gaps and takes appropriate corrective actions as needed
• Supports internal and external audits
• Leads quality system improvement projects as required.

Budget managed (if applicable):

• N/A