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 safety and 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 Bachelor’s degree in Engineering (Bio Medical Preferred) or related scientific field

Experience:

• 7 yrs minimum (Preferably Medical 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