Senior Quality Engineer II

Werfen; Bedford (AL); On-site; USD 150,000 - 180,000; Full time

Benefits offered by this job

Medical insurance

Dental coverage

Vision insurance

401(k) with company match

Paid vacation and sick leave

Job summary

Werfen seeks a senior quality/regulatory leader to drive compliance across the product lifecycle, from design to distribution, ensuring robust documentation, risk management, and product realization processes. You will influence cross-functional teams to uphold quality standards and meet regulatory expectations.

The role emphasizes deep knowledge of medical device quality systems, Lean/Six Sigma practices, and effective communication with auditors and stakeholders.

Qualifications

• Knowledge of domestic and international quality/regulatory standards related to medical devices and diagnostics.
• Lean and Six Sigma quality management techniques and statistics for change evaluation.
• Understanding of IL products, technology, manufacturing processes, and patient requirements.
• Ability to apply regulatory data reviews, risk management, and design changes to meet compliance and business objectives.

Responsibilities

• Lead cross-functional teams to ensure design control and product realization requirements are met.
• Advise on adherence to procedures, standards, and regulatory guidelines across the product lifecycle.
• Review and approve change orders affecting product performance, processes, labeling, and communications.
• Identify compliance gaps and drive corrective actions and CAPA in collaboration with stakeholders.
• Support audits and inspections with sound documentation and defensible evidence.

Skills

Quality standards knowledge

Lean Six Sigma

Regulatory compliance

Risk management

Education

Bachelor's degree in engineering or science

Job description

Introduction

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.

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 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.

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

Responsibilities

Key Accountabilities

• 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 IL 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 IL products.
• Provides guidance on compliance of software to procedures and standards including cyber security and privacy requirements
• Works with manufacturing, R&D, Service, Distribution, 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
• Other duties as assigned

Secondary Functions

• Identifies compliance gaps and takes appropriate corrective actions as needed
• Defends documents and procedures internal and external audits
• Leads 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.

Qualifications

Skills & Capabilities:

The ideal candidate for this position will exhibit the following skills and capabilities:

• 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.
• Working knowledge of IL 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.

Minimum Knowledge & Experience required for the position:

• Education: Bachelor's degree or equivalent in engineering or science
• Experience: A minimum of 10 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory or 7 years of experience with an advanced degree.
• Additional Skills/Knowledge:
  • 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
  • Language: English

Travel Requirements:

Approximately 10% of time

The annual base salary range for this role is currently $150,000 to $180,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

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.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. 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.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com