This position is responsible for quality leadership and support of new product development. This individual will ensure design control requirements are implemented and followed, will support multiple product development projects and will ensure that the quality objectives are met during the product development and design transfer life cycle. This position is also responsible for the leading post market surveillance activities and product risk management programs.
This individual will be an active mentor and coach for all professionals reporting under this functional quality area as well as other Inspire personnel globally. This individual is also responsible for ensuring compliance with global quality system regulations and standards as well as supporting corporate objectives.
- Develop and executes new product development quality strategies and establish product performance goals for the quality organization.
- Develop post market surveillance quality plans and measure results. Drive appropriate change based on the results.
- Ensure effective execution of the quality engineering activities in support of new product development, sustaining engineering projects and when applicable supplier changes.
- Manage quality support for design assurance activities, including quality planning, design verification, design validation, standards compliance, design reviews, design transfer and risk management.
- Manage quality support for post market surveillance activities, including product performance, complaint handling, medical device/vigilance reporting, regulatory adverse event inquiries, product risk management, and post market process reporting.
- Perform, support, mentor and coach others on effective root cause investigations and CAPA actions to maintain effective and compliant quality systems and products.
- Lead, develop, engage, and mentor organizational talent
- Recruit top candidates for quality positions
- Demonstrate effective change leadership
- Continuously improve quality processes and quality system with the goal of improving patient outcomes, reducing risk, maintaining regulatory compliance, and improving product quality/reliability.
- Applies and mentors/coaches the application of technical principles, theories, concepts and quality tools to complex systems and process
- Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
- Complete training requirements and competency confirmations as required for this position within the required timeline.
- Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.
- Ensure all direct reports maintain training records that comply with applicable quality system requirements.
Bachelor’s degree in science, engineering, technology, or biomedical discipline
Master’s degree in a technical or scientific field
- Minimum of 10 years experience in a medical device quality management role
- Minimum of 5 years in a medical device design assurance role and/or medical device post market role
- Minimum of 5 years in a medical device released product role, including CAPA management
- In depth knowledge of and implementing global medical device regulations (21 CFR 820, 803, 806, 801, 821, 822, 830, JPAL, AIMDD, etc).
- Demonstrated leadership and project management skills with the ability to prioritize and execute.
- Proficient with of MS Word, Excel and PowerPoint
- Proficient with other MS applications (i.e.; Power BI, SharePoint, OneDrive, etc.)
- 15 years’ experience in a medical device quality management role
- Experience working directly with FDA, Notified Bodies or other geographic regulators
- Experience working in another regulated industry (pharma, tissue, etc)
- Demonstrated application and implementation of a risk management program in accordance with ISO 14971.
- Demonstrated high level of strategic thinking, customer/patient focused risk assessment and judgement.
- Demonstrated creative and effective problem solving and out of the box thinking for design, reliability and compliance solutions.
- Strong interpersonal and communication (both verbal and written) skills. Ability to facilitate teams and deliver presentations.
- Effective relationship management, ability to network, support and influence across the entire organization.
- Proven success in coaching, developing and managing people.