This position is integral to the design, manufacture, distribution and service of our products and related accessories. This position leads 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. This position is responsible for the oversight and development of supplier quality control activities at all applicable manufacturing locations.
ESSENTIAL/PRIMARY DUTIES:
Directs and manages Quality Assurance activities relating to supplier quality
Interfaces with customers and suppliers on quality and business issues
Executes change management with a focus on standards and compliance excellence
Participates in the development, maintenance, and use of effective quality standards
Establishes effective quality measurements throughout Midmark flow paths
Analyzes and presents quality metrics at monthly meetings and management reviews
Directs effective and efficient continuous quality improvement efforts
Acts as an active member of the Quality and Regulatory Affairs team to align processes with other divisions and sites to align and meet business goals
Hires, trains and develops quality staff and conducts performance reviews to assure highly effective teammates
Works cross-functionally to create consistent business processes that align with the organization’s vision and strategic direction
Partners with functional leadership to set departmental and organizational strategic direction
Partners with key stakeholders to develop and support business cases for projects and initiatives
Reviews and approves SOWs from third parties
Establishes and enforces guidelines to ensure consistency of processes and data
Ensures that processes comply with applicable regulatory requirements
Interfaces with process stakeholders (internal and external) and develops appropriate metrics to continuously measure and improve processes
Develops supplier’s quality capabilities such as through Six Sigma DMAIC, DMADV, gaging and measurement techniques, OEM design controls, documentation best practices, etc.
Leads objective and key result (OKR) initiatives for process improvement, automation, and teammate development across all applicable facilities
SECONDARY DUTIES:
Provides support for corporate led projects, mergers, and acquisitions
Supports the Six Sigma Program Lead with training material development, pipeline of trainees and continuous improvement projects
Manages department budget
Other duties as assigned
EDUCATION and/or EXPERIENCE:
Bachelor of Science in Engineering or related degree and 10 years of current good manufacturing practice experience in the Quality and Regulatory Affairs organization, including 5 years supervisory/managerial experience, or equivalent combination of education and experience.Master’s degree, preferred. Management experience in the medical device manufacturing industry in the FDA Class I and II medical devices, required.
COMPETENCY/SKILL REQUIREMENTS:
Knowledge of department functions and processes and how they connect to other departments
Ability communicate change
Ability to resolve conflicts and facilitate change
Knowledge of Minitab, R, or other statistical analysis program(s)
Knowledge of Oracle (ERP)
Knowledge of Six Sigma DMAIC
SUPERVISORY RESPONSIBILITIES:
Leads and directs the work of other teammates and has full authority for personnel decisions.
About Us
Founded in 1915, Midmark Corporation is the only company transforming healthcare experiences through innovative design within the medical, dental and animal health environments. With more than 2,200 teammates worldwide, Midmark focuses on harmonizing space, technology and workflows, creating a better experience for caregivers and patients at the point of care. The Midmark headquarters and innovation hub are located in Versailles, Ohio, which is also home to the Midmark Experience Center, Design Center, Technology Center and our largest manufacturing facility. Midmark maintains eleven additional locations in the United States, including four innovation hubs, and has subsidiaries in India and Italy.