Director, Quality Systems Job Details | Olympus Corporation of the Americas

Olympus•Westborough, MA

39d•Onsite

About The Position

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.

Requirements

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 at Sr. And 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 makedecisions and commit to a clear course of action; comfortable making decisions based on partial information.
Organization Agility to adapt to a changingenvironment 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.

Nice To Haves

MBA Preferred.
Medical Device Experience preferred
Black Belt Certification preferred.
Comprehensive understanding of principles and concepts of Process Excellence, Statistical Process Control, and Applied Statistics preferred.

Responsibilities

Leads and directs Quality System team members in the Americas.
Manages the development and performance of staff.
Ability to assess and develop teamtalent 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 orsystems to support the Quality Systems vision for the OCA region.
Drives the development and deployment of innovative global policies requirements andstrategies 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.