Principal Design Quality Engineer

Overview

The Principal Design Quality Engineer opportunity 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 saftey and quality.

Responsibilities

Key Accountabilities

• Authoring and overseeing quality plans that meet compliance standards, including those related to product design, saftey and reliability.
• Leading the process to ensure designs adhere to regulatory and quality requirements, including risk management activities.
• Overseeing design verification and validation activites, including testing, analysis and reviews.
• Leading and driving continious improvement initiatives to enhance product quality, efficiency and customer satisfaction.
• Providing leadership and mentorship to other engineers, fostering a culture of quality and saftey.
• Lead risk management initiatives for the entire product lifecycle in accordance with ISO 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 lifecycle projects and new product development teams. Represent Quality for new and existing product improvement, manufacturing transfers, and quality plan intiatives
• 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.

Qualifications

Minimum Knowledge & Experience Required :

Education : Bachelor’s degree in Engineering (Bio Medical Preferred) or related scientific field

Experience : 7 years (Preferrably Medical Device Industry)

Skills & Capabilities :

Travel Requirements : 0%

Werfen appreciates and values diversity. We are an Equal Opportunity / Affirmative Action Employer M / F / D / V

We operate directly in over 30 countries, and in more than territories through distributors. Annual revenue is approximately $2 billion and more than 5, employees around the world comprise our Werfen