Principal Quality Engineer

Werfen • Bedford, MA

13h

About The Position

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.

Requirements

• Education: Bachelor's degree or equivalent in engineering or science
• Experience: 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.
• Duties necessitate broad and thorough 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

Nice To Haves

• ASQ Quality Engineering Certification - Desirable
• LEAN/Six Sigma Certification - Desirable

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
• 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.

Benefits

• This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave.
• Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level