Principal Design Quality Engineer Transfusion and Transplant

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 7000 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. Were passionate about providing healthcare professionals with the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

This is a leadership role responsible for ensuring the quality of products throughout the design and development process. This role will lead quality improvement initiatives develop and implement quality plans and mentor other quality engineers all while fostering a culture of safetyand quality.

Key Accountabilities

• Authoring and overseeing quality plans that meet compliance standards including those related to product design safety and reliability.
• Leading the process to ensure designs adhere to regulatory and quality requirements including risk management activities.
• Overseeing design verification and validation activities including testing analysis and reviews.
• Leading and driving continuous improvement initiatives to enhance product quality efficiency and customer satisfaction.
• Providing leadership and mentor-ship to other engineers fostering a culture of quality and safety.
• Lead risk management initiatives for the entire product life-cycle in accordance with ISO 14971 and related regulatory requirements. Assure applicable quality decisions are derived from the appropriate risk management document in accordance to the quality system.
• Support on-going product compliance technical documentation and on-going market authorization through review and response to competent authority feedback in a timely manner.
• Support teams to establish product development requirements (e.g. Design Input documents design verification and validation requirements risk management requirements usability requirements CTQ Identification etc.)
• Serve as a Quality core team member on sustaining product life-cycle projects and new product development teams. Represent Quality for new and existing product improvement manufacturing transfers and quality plan initiatives
• Performs other duties and responsibilities as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key Relationships

Working with cross-functional teams including Operations Research and development Regulatory Affairs Marketing and Quality Assurance.

Minimum Knowledge & Experience required for the position:

Education:

• Minimum Bachelors degree in Engineering (Bio Medical Preferred) or related scientific field

Experience:

• 7 yrs minimum (PreferablyMedical Device Industry)

Skills & Capabilities

• Able to work in a team environment and collaborate
• Demonstrates knowledge of products services procedures policies systems and company organization as it relates to job requirements.
• Display PC skills with Microsoft Office (Word Excel) and other desktop functions at an intermediate level.
• Strong written and oral communication skills (timely clear concise accurate conclusive influential targeted to audience.
• Excellent teamwork skills including influencing and building rapport with internal departments and stakeholders.
• Excellent problem solving skills including demonstrated critical thinking skills and application of structured problem solving methods and tools.
• Able to lead and make independent decisions in collaboration with cross functional teams.

Travel Requirements:

• N/A

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination harassment or retaliation based upon an individuals 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. If you have a disability and need an accommodation in relation to the online application process please contact for assistance.

We operate directly in over 30 countries and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7000 employees around the world comprise our Werfen team.