Senior Quality Engineer II

About the role

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.

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

Essential Functions

• 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 in 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.

Requirements

Skills & 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

• 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
• 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

Pay

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 a performance-based bonus.

Benefits

• Medical, dental, and vision insurance
• 401k plan retirement benefits with an employer match
• Paid vacation and sick leave