Senior Quality Engineer Job - Bedford, MA, United States - Werfen

Description

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.

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 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.

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.

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.
Defends relevant quality topics in audits and corrective actions to improve and maintain compliance of the QMS.

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
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.
Defends documents and procedures in internal and external audits
Participates in and may lead quality system improvement projects as required.


Internal Networking/Key Relationships:

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.
Working knowledge of domestic and international quality/regulatory standards related to our products
Knowledge of quality management techniques (Lean, Six Sigma) and statistical techniques required to measure and confirm significant changes.

Demonstrates judgement commensurate with experience regarding application of regulatory requirements to data review, reports, design changes, risk management, etc.

Demonstrated understanding of risk based approach to processes and decisions.

Performance Standards:
Independence: self-motivated-works under minimal supervision
Bachelor's degree or equivalent in engineering or science
A minimum of 8 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory or 5 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.
ASQ Quality Engineering Certification - Desirable
LEAN/Six Sigma Certification - Desirable


International Mobility:

Travel Requirements:

Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law.

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