Jobs for Veterans, Veteran Job Board | GiJobs.com

Post Jobs

Job Information

Hill-Rom Global Quality Systems Director - Medical Device in Batesville, Indiana

Description

  • 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

#INDHR#INDHR

Qualifications

QUALIFICATIONS:

  • 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).

Job: Quality

Primary Location: United States-Indiana-Batesville

Schedule Full-time

Travel No

Posting Entity Hillrom

Req ID: 19124979

DirectEmployers