Director, Quality Systems

Job Description

Oversee all aspects of the Quality Management System (QMS) across the Americas. Ensures the QMS design maintenance execution and governance supports business objectives through: proactive monitoring and application of global regulatory requirements within the regional QMS; leading the governance of the QMS in the Americas; development of employee QMS awareness knowledge and application; lead quality sub-system process improvement projects to increase efficiency of the QMS through enhancing employee interaction experience or making improvements to how product quality is approached.

• Leads and directs Quality System team members in the Americas.
• Manages the development and performance of staff.
• Ability to assess and develop team talent to support business objects and personal objects of employees.
• Prioritize resources based on the strategic objectives of the organization.
• Establishes the departments objectives (MBO) to meet Quality Objectives organizations goals and strategic plan.
• Provides leadership in establishing processes or systems to support the Quality Systems vision for the OCA region.
• Drives the development and deployment of innovative global policies requirements and strategies for Quality Systems.
• Change agent to break down barriers to prepare and influence direct team other functions and OCA sites to new ideas and ways to execute Quality Systems sub-systems to improve Olympus compliance profile.
• Monitors plans and applies Global regulatory or Olympus requirements into the QMS regionally and at the local level within the Americas.
• Leads quality sub-system process improvement projects to increase efficiency of the QMS Influence regional and global QARA com QMS strategic direction and initiatives.
• Leads QMS governance through execution of Management Review and CAPA sub-system ownership for the region.
• Accountable for QMS KPI execution results Develops QMS competency for all employees.
• Supports QARA Pillars QMS requirements.
• Aligns Quality System resource to support QARA Pillars across the region.
• QMS Subject Matter Expert to support QARA Compliance team during external and internal audits.
• Performs other related duties as assigned by management.

• Bachelor of Science required.
• Minimum of 10 years Regulated Quality Experience.
• Minmum of 7 years experience managing people ideally across multiple locations sites countries.
• Minimum of 7 years combined experience working in Quality Systems Document Control and Training.
• Minimum of 7 years experience managing the business aspects of quality and regulatory projects.
• Good analytical toolkit.
• Ability to influence outside of direct control  International CQE and/or Six Sigma.
• Leadership through inspiring the team to execute commitments on time and to expectations.
• Building and leading a team with integrity and unity.
• Change agent to break down barriers to prepare and influence direct team other functions and OCA sites to new ideas and ways to execute Quality Systems sub-systems to improve Olympus compliance profile.
• Ability to assess and develop team talent to support business objects and personal objects of employees.
• Prioritize resources based on the strategic objectives of the organization.
• Able to quickly make decisions and commit to a clear course of action; comfortable making decisions based on partial information.
• Organization Agility to adapt to a changing environment and new ideas with speed.
• Able to identify and articulate the strategic vision and direction for department to support the business objectives.
• Thorough knowledge of 21 CFR 820 and ISO 13485 required.
• Working knowledge of international medical device quality system requirements required.
• Complete understanding and application of principles concepts and practices of production manufacturing and quality system procedures required.
• Demonstrated success in the design and deployment of innovative quality systems.
• Travel up to 20% of the time availability to take evening and early morning teleconferences.

• MBA Preferred.
• Medical Device Experience preferred
• Black Belt Certification preferred.
• Comprehensive understanding of principles and concepts of Process…