Olympus Corporation of the Americas Director, Quality Systems in Westborough, Massachusetts
Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY; TENNESSEE, BARTLETT; WASHINGTON, REDMOND
Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day.
Let’s inspire healthier lives, together.
The Director, Quality Systems oversees all aspects of the Quality Management System (QMS) across the Americas. They ensures the QMS design maintenance execution and governance and 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 is required, an MBA Preferred.
Minimum 10 years of Regulated Quality Experience, Medical Device Experience preferred .
Minimum 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.
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.
Travel up to 20% of the time availability to take evening and early morning teleconferences
Good analytical toolkit.
Ability to influence outside of direct control at Senior and International CQE and/or Six Sigma Black Belt Certification preferred.
Comprehensive understanding of principles and concepts of Process Excellence Statistical Process Control and Applied Statistics preferred.
Ability to handle multiple projects simultaneously and to discern major quality issues.
Demonstrated success in the design and deployment of innovative quality systems.
We realize work isn’t just a job to you.
It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.
Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.
Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com .
Olympus…True To You. True To Society. True To LIFE.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough ||