The Site Quality Leader is the designated Quality Management Representative (QMR) for all aspects of Quality System implementation within the Milwaukee manufacturing facility. This role provides leadership to all functions within the Cardiology Quality Organization to achieve Quality goals and objectives. The Site Quality Leader is responsible for achieving Quality scorecard metrics, operational targets and the implementation and maintenance of an effective and compliant Quality Management System supporting continued certification to ISO 13485 and MDSAP requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- The quality leader is responsible to develop a quality roadmap to ensure overall compliance of all Hillrom sites supporting the cardiology business and involved in designing, manufacturing, and servicing the cardiology devices
- The quality leader serves as Quality Management Representative for the Milwaukee manufacturing facility as well as the Bologna design facility including hosting third party inspections and audits and organizing and conducting periodic Management Reviews of the Quality System.
- Develop, implement and maintain a site quality system in compliance with MDSAP and ISO 13485 requirements to ensure continued certification and allow distribution of devices in US, EU and other markets.
- Provide strategic direction and leadership to the QA Organization to ensure activities adhere to the highest standards of compliance and product quality.
- Direct the implementation of corrective and preventive actions, audits and complaint investigations.
- Ensure product containment of manufacturing non-conformances, to include immediate corrective activities as appropriate and the determination of systemic corrective and preventive actions.
- Oversee supplier quality activities for the manufacturing facility, including the support of supplier selection, qualification, and control.
- Identify and mitigate gaps between Quality System requirements and applicable regulations and corporate requirements.
- Establish and Manage Site Quality Plans to ensure continuous improvement and remediation activities are conducted as needed
EDUCATION AND EXPERIENCE:
- This position requires a formal education, bachelor’s degree in science and/or Engineering
- A Master’s Degree or Quality certification such as ISO lead auditor or CQA/CQE is preferred
- 8- 10 minimum years of experience required within the pharmaceutical or medical device industry with at least 3 years in a people manager role.
QUALIFICATIONS AND SKILLS:
Critical thinking ability, sound quality decision making, technical understanding of complex issues, thorough knowledge of regulatory requirements and successful interactions with regulatory agencies (FDA, notified bodies). Ability to communicate clearly, develop strategies and influence outcomes.