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Quality System Manager

JOB SUMMARY:As the Quality System Manager you will be responsible for the successful operation of the Quality Management System of the organization at the assigned facility. This position is integral to the design, manufacture, distribution and service of our products and related accessories. This position also shares responsibility for the end-to-end processes across functional departments and geographic boundaries for the Q&R.  This is a strategic role that is also accountable for building, standardizing and maintaining processes within the business line(s) to create alignment between the organization's vision and strategic direction.   Management experience required in the medical device manufacturing industry in the FDA Class I and II medical devices. ESSENTIAL/PRIMARY DUTIES: Direct and manage Quality Assurance activities relating to Post-Mark Surveillance, Internal Audit and CAPA for the location. Interface with regulatory agencies during inspections and on quality issues as Deputy Management Representative.   Interface with customers and suppliers on quality and business issues.  Change management with a focus on standards and compliance excellence.  Participate in the development, maintenance and use of effective quality standards.  Establish effective quality measurements throughout Midmark flow paths.  Analyze and present quality metrics at Monthly meetings and Management Reviews.   Direct effective and efficient continuous quality improvement efforts. Active member of the Quality and Regulatory Affairs team to align processes with other divisions and sites to align and meet business goals.  Hire, train and develop quality staff and conduct Performance Reviews to assure highly effective teammates. Work cross-functionally to create consistent business processes that align with the organization's vision and strategic direction Partner with functional leadership to set departmental and organizational strategic direction Partnering with key stakeholders to develop and support business cases for projects and initiatives Review and approve SOWs from third parties Own and manage the enhancements through the Help Desk queue that directly impact the area  Responsible for establishing and enforcing guidelines to ensure consistency of processes and data  Lead process reviews to ensure consistency and compliance between process design and actual user process. Identify gaps in processes, systems, and implement improvements. Ensure that processes comply with applicable regulatory requirements.   Interface with process stakeholders (internal and external) and develop appropriate metrics to continuously measure and improve processes  Resolve conflicts, manage resistance, and facilitate change. SECONDARY DUTIES: May review and/or approve process-related work instructions Provide support for Corporate led projects, mergers and acquisitions. Other duties and tasks may be assigned EDUCATION and/or EXPERIENCE: Bachelor of Science in Engineering or related degree and or 10+ years of current good manufacturing practice experience in the Quality and Regulatory Affairs organization including 5+ years supervisory/managerial experience.  Masters of Science in Engineering or related degree with 5+ years of current good manufacturing practice experience in the Quality and Regulatory Affairs organization including 5+ years supervisory/managerial experience.  Medical Device experience required. COMPETENCY/SKILL REQUIREMENTS:  Knowledge of his/her department's function and processes and how they connect to other departments within the organization Ability to affect and communicate change SUPERVISORY RESPONSIBILITIES:  The position will have a direct report(s).
Salary Range: NA
Minimum Qualification
5 - 7 years

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