Principal Quality Engineer

Werfen-posted 5 days ago

Full-time • Mid Level

Bedford, MA

5,001-10,000 employees

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Overview Position Summary: 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.
Works closely with other functions to generate compliant documents by interpreting and explaining 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.

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.
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 multi-function 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
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

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

medical, dental, and vision insurance
401k plan retirement benefits with an employer match
paid vacation and sick leave
eligible for participation in a commission plan
eligible for a performance-based bonus

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