This position is responsible for quality leadership and support of Inspire’s quality system, as well as driving QMS process changes to comply with global requirements. This individual will ensure electronic QMS software implementations are documented, tested and controlled such that both the QMS process workflow and implementation process meet global regulatory requirements. This position is also responsible for the leading configuration assurance, QMS compliance & audit along with the material quality program.
This individual will be an active mentor and coach for all professionals reporting under these functional quality areas 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.
- Maintain an effective quality system including QMS structure, quality planning, execution of all QMS processes, monitoring of metrics and management review.
- Manage interactions with external agencies (FDA, Notified Bodies, and Competent Authorities) for inspections and audits.
- Lead QMS process improvement projects to increase efficiency of the QMS and move to an electronic based system.
- Develop and implement global quality plan and lead the implementation of quality metrics that drive business objectives as well as compliance.
- Develop and implement new electronic QMS process workflows to drive compliance with current regulations as well as new geographic regulations where products are/or planned to be distributed.
- Ensures QMS competency for all Inspire employees and contractors
- Manage quality support for quality systems activities including internal/external audits, process monitoring/metrics, quality planning, development of process workflow tools, process improvements, QMS management reviews, QMS training, standards library and any product recall decisions.
- Manage quality support for electronic QMS implementations including software validation (IQ/OQ/PQ), workflow development, configuration assurance and change management.
- Manage quality support for material and supplier quality activities including selection, qualification, audit, changes, corrective actions and the supplier 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
- Applies and mentors/coaches the application of quality principles, theories, concepts and 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 15 years working in medical device quality systems
- Minimum of 5 years in a medical device compliance and/or audit role
- Minimum of 2 electronic QMS system/workflow implementations
- 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 on product recalls
- Demonstrated QS leadership by:
- Implementing and obtaining certification (ISO) of a quality management system
- Implementing and validating an electronic QMS software tool to transition existing paper processes into electronic workflows
- 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 quality system 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.