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| Advanced Quality Assurance and IN Open (J#45576) Title: Advanced Quality Assurance and Company: Hill Rom Company Inc Job Description The QA/RA Engineer is responsible for ensuring the effectiveness of the Quality System in order to achieve and maintain a state of business excellence for Hill-Rom. The QA/RA Engineer participates in setting the corporate direction for the effective deployment and execution of the various Quality System processes and will ensure integrity, consistency, and regulatory compliance. The QA/RA Engineer will develop and implement programs and ensure consistency in identifying, investigating, reporting, measuring and responding to compliance issues through development and implementation of consistent tools, training programs and actionable metrics. ESSENTIAL DUTIES AND RESPONSIBILITIES Other duties may be assigned: - Participate in establishing strategic direction for quality system activities that are aligned with business and quality initiatives and in compliance with all regulatory requirements. - Develop, implement, and maintain procedures and work instructions to support the administration of the quality system. - Recommend and implement improvements to the quality system processes driven by new regulations, industry standards, new technologies, and internal business needs. - Corporate Quality Systems process owner for the global corrective & preventive action quality system. o Facilitate weekly Corporate Corrective Action Board (CAB) meetings. o Accountable for the creation of Corporate CAB presentations and maintaining meeting minutes. o Facilitate discussions with CAPA owners to drive completion of investigations, root-cause analysis, impact analysis, and closure of events. o Facilitate regular event/CAPA status and metric reports to inform senior management in a timely manner. o Monitor investigations and approvals to ensure that all the required information is captured and documented with relation to events. - Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement - Escalate issues to senior management, as appropriate. - Ensure adequate training is conducted and competency is maintained among key process stakeholders. - Participate in external and internal regulatory inspections and attend Management Review meetings as required. SUPERVISORY RESPONSIBILITIES: - Does not have direct supervisory responsibilities. - Strong influencing, negotiations and leading without direct line authority experience is required. More... | |||
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