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Director Customer Quality, AIRs and Emerging Issues

Olympus Medical Systems

Olympus Medical Systems

Customer Service, Quality Assurance
Westborough, MA, USA
Posted on Tuesday, July 2, 2024

Working Location: MASSACHUSETTS, WESTBOROUGH; CALIFORNIA, SAN JOSE; PENNSYLVANIA, CENTER VALLEY

Workplace Flexibility: Field

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

We deliver on our purpose and our core values by staying True to Life.

**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

Job Description

  • Leads and directs cross-functional team to document responses to requests for additional information from regulators ensuring communicationsadhere the Global Quality System and applicable regulatory requirements.
  • Responsible for reviewing complaint handling requests for additional information and other post market responses prior to submission to regulators.
  • Develops a global post market regulator communication process including tracking and trending of responses to regulators.
  • Provides guidance, training, coaching to team quality compliance matters including on communication with regulatory agencies regarding post market issues.
  • Gathers, maintains, and distributes Emerging Issues communications to internal stakeholders .
  • Identifies issues that require escalation to leadership, and potential issues for consideration for risk assessment or Health Hazard Assessment

Job Duties

  • Develops and implements the global regulatory requests for additional information communication process and activities.
  • Responsible for the completion of regulator requests for additional information to the US FDA, and other Regulatory Authorities as applicable.
  • Leads cross functional teams on investigating, assessing and authoring responses.
  • Tracks, trends, and analyzes requests for additional information from regulators, respective corrective actions, and remediations; provide inputs to upstream processes for improvements.
  • Gathers, collates, and maintains Emerging Issues report; distributes and presents to internal stakeholders.
  • Identifies issues that require prompt notification and presents/communicates to Olympus senior leadership in a clear and concise manner.
  • Escalates potential safety issues for risk assessment or health hazard assessment.
  • o Manages the development of Global Hot Topic communications.
  • o Works together with the Customer Quality organization to identify, access, and analyze data that have impact on the company’s compliance with overall quality systems.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Advise management on potential improvements or enhancement to quality systems and processes in the company.
  • Develops new approaches to solve problems identified as part of the team.
  • Participates in the implementation of Global Customer Quality initiatives and programs throughout the Global organization, as required.
  • Participates in the CAPA process as required as an assignee or project team member.

Job Qualifications

Required:

  • Bachelor’s degree in a science, engineering discipline, or equivalent
  • A minimum of 15 years of related professional experience in the medical device industry.
  • A minimum of 5 years managing direct or indirect teams in the medical device environment.
  • Experience developing and managing communications to regulatory agencies.
  • Experience working with, presenting to and communicating with executive leadership.
  • Requires background and familiarity with applicable regulatory requirements, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485,Health Canada, MHLW, ANVISA, and TGA.
  • Experience in supporting sites / organizations through US FDA, Notified Body, and other International Regulatory Agency Audits.
  • Experience writing, reviewing, and providing feedback on requests for additional information or audit responses.
  • Experience working in a global organization and collaborating with multiple regions (Americas, EMEA, APAC, China & Japan) / company locations.
  • Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones. International travel up to 25% of the time should be expected.

Preferred:

  • Interpersonal skills to develop and manage good working relationships with all Olympus locations and internal departments (R&D,Manufacturing, Supply Chain, Regulatory, Quality, Regulatory, etc.…).
  • Proven leadership, teamwork, collaboration and infl uencing skills.
  • Ability to work eff ectively and with agility in a fast paced and dynamic environment.
  • Working knowledge of problem-solving skills good statistical and analytical skills.
  • Strong written and verbal communication skills.
  • Proficient in the use of Information Technology.
  • Fluent in English language

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.

  • Competitive salaries, annual bonus and 401(k)* with company match
  • Comprehensive Medical, Dental, Visions coverage effective on start date
  • 24/7 Employee Assistance Program
  • Free virtual live and on-demand wellness classes
  • Work-life balance supportive culture with hybrid and remote roles
  • 12 Paid Holidays
  • Educational Assistance
  • Parental Leave and Adoption Assistance
  • Volunteering and charitable donation match programs
  • Diversity & Inclusion Programs including Colleague Affinity Networks
  • On-Site Child Daycare, Café, Fitness Center**

*US Only

**Limited locations

We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks.

The anticipated base pay range for this full-time position working at this location is $128,490.00 - $179,886.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.

About us:

Our 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 costs, and enhance the quality of life for patients and their safety.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

Let’s realize your potential, together.

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.

Applicants with Disabilities: As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)