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Olympus America Inc. Executive Director, Global Complaint Center of Excellence in Southborough, Massachusetts

Job Requirements::

REQUIRED QUALIFICATIONS:

  • Bachelor's degree required, MBA Preferred

  • Minimum 10 years Regulated Quality Experience, Medical Device Experience preferred

  • Minimum 7 years Experience managing people , ideally across multiple locations, sites, countries

  • Minimum 7 years combined Experience working in Quality Systems, Document Control and Training

  • Minimum 7 years Experience managing the business aspects of quality and regulatory projects

  • Good analytical toolkit.

  • Ability to influence outside of direct control at Senior and International levels.

  • 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.

  • 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.

  • Ability 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.

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.

Job Duties::

As a COE (Center of Excellence) Executive Director working on the Quality team, you will be empowered and inspired to do your best work. You will contribute to our mission by leading a team to manage and monitor global governance of our complaint handing, influence the compliance profile that contributes to product quality, and develop and coach the Center of Excellence team to success.

  • Leads and directs Global Complaint Center of Excellence team members.

  • 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 department's objectives (MBO) to meet Quality Objectives, organization's goals and strategic plan.

  • Provides leadership in establishing processes or systems to support ETQ.

  • Establish and manage the global complaint process and ETQ.

  • Oversee the change process, manage the OGBR-M.

  • Convert Risk Summary Sheet to automation format in ETQ or other automation

  • Provide oversight of training that supports the Global Complaint process

  • Perform regular data analysis to identify safety and compliance signals in the complaint process

  • Manage the Quality Assurance Agreements between Olympus entities as they relate to the complaint process as well as oversee the compliance to those agreements.

  • Manage the Global Adverse Event Reporting function for all of Olympus.

  • Perform all other duties as assigned.

Job Description:

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. We’re currently looking for a Executive Director, Global Complaint Center of Excellence to join us in any of our US offices.

Let’s inspire healthier lives, together.

The Executive Director, Global Complaint Center of Excellence establishes and manage a Global Complaint Center of Excellence overseeing governance of ETQ and the complaint process (OGBR-M), Global Complaint Training, Global Trending and Signal Detection, Global Complaint Management/Auditing, and Global Adverse Event Reporting.

About Us:

At Olympus, we put a lot of good back into the world, and what we do really matters. We are committed to making people’s lives healthier, safer and more fulfilling every day by crafting innovative optical and digital solutions in medical technologies, microscopy, industrial solutions, cameras, and audio recorders.

We view our relationship with and commitment to our employees with the same passion. Everything we do at Olympus is a reflection of our vision, and everyone here helps to make it a reality. We’re invested in our employees, great ideas, and how they impact the communities around us. We see the world through multiple lenses and come together to find the right answers; the best solutions.

THAT’S OLYMPUS.

TRUE TO YOU. TRUE TO SOCIETY. TRUE TO LIFE.

Olympus Surgical Technology America at http://www.olympus-osta.com/

Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification. EOE Minorities/Females/Veterans/Disabled

Posting Locations:

California, San Jose, Florida, Miami, Massachusetts, Boston, Massachusetts, Southborough, Minnesota, Minneapolis, Tennessee, Memphis

Company URL:

Olympus Surgical Technology America at http://www.olympus-osta.com/

Posting Title:

Executive Director, Global Complaint Center of Excellence

Work Location:

Southborough GYR ACMI Inc

Job Family:

Quality Assurance

Auto req ID:

5706BR

5706BR

Olympus is an Equal Opportunity Employer, and our policies prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification.

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