Ensuring the quality of products throughout the design and development process, leading quality improvement initiatives, developing and implementing quality plans, and mentoring other quality engineers while fostering a culture of safety and quality.
Requirements
- 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.
- Excellent problem solving skills, including demonstrated critical thinking skills and application of structured problem solving methods and tools.
Responsibilities
- 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.
- 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.)
Other
- Minimum Bachelor’s degree in Engineering (Bio Medical Preferred) or related scientific field
- 7 yrs minimum (Preferably Medical Device Industry)
- Able to work in a team environment and collaborate
- 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.
