Hill-Rom Global Quality Systems Director - Medical Device in Batesville, Indiana
Global Quality System process owner
Develop and implement Quality System strategy and architecture for the company
Ensure regulatory compliance for corporate Quality System
Operational responsibility for the Corporate Data and Document Management organizations
Leadership of the Quality Systems Council (QSC), CAPA and Training
Coordination of Executive Management Review and global Quality Scorecard
Manage corporate regulatory inspections
Manage audit preparedness and readiness
Liaison with sites on NB and regulatory agency audits and responses
Thorough knowledge and understanding of medical device regulations and standards, including but not limited to QSR, CMDR, Medical Device Directive, ISO Quality System and other applicable industry requirements is required.
Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills; and the ability to look beyond obvious answers in order to understand the impact on other areas is required.
Exceptionally strong leadership and influencing skills. Must have ability to make effective presentations to all levels of the organization.
The proven ability to prioritize and manage multiple projects and meet deadlines is required.
Must have the ability to work in both a collaborative (team) environment as well as perform independent work as required.
Experience building a high performance team, managing performance of team members with varying levels of skill and experience, and mentoring high potential individuals to achieve greater impact on the organization.
Strong appreciation of the impact of regulatory bodies on medical device product lifecycle is required.
Experience working with diverse cultures and employees.
Strong knowledge of tools and techniques for failure investigations.
Successful track record for identifying and implementing systemic corrective and preventive actions.
High degree of individual ownership and accountability.
Ability to manage regulatory agency inspections and coordinate responses
ASQ Certifications for Auditing and/or Quality Management is preferred.
Occasional (<20%) overnight travel as required based on business need including international travel.
May involve minimal bending and lifting
EDUCATION AND/OR EXPERIENCE:
Bachelor’s degree in a related medical, science or regulatory discipline required. Engineering degree strongly preferred.
10 years in the medical device industry or related GMP environment or equivalent.
5 years experience leading direct reports.
Demonstrated strong proficiency with Microsoft systems (Excel, PowerPoint, Word, and Project).
Primary Location: United States-Indiana-Batesville
Posting Entity Hillrom
Req ID: 19124979