Senior Manager Customer Quality Compliance Operations Specialist

4 days ago

Westborough, Massachusetts, United States Olympus Full time

Job Title: Senior Manager Customer Quality Compliance Operations

Job Summary:

The Senior Manager Customer Quality Compliance Operations will lead cross-functional teams to investigate and develop responses to internal and external audit findings and observations. This role will be responsible for reviewing and authoring all Customer Quality external audit responses prior to submission to corporate compliance and/or regulators. The position will ensure adequate tracking and monitoring of all external and internal Customer Quality commitments to facilitate timely implementation and completion of actions.

Key Responsibilities:

  • Implement and maintain the Customer Quality external and internal audit response process and activities.
  • Monitor for timely completion of applicable Customer Quality commitments to US FDA, and other Regulatory Authorities as applicable.
  • Lead cross-site/functional teams on investigating, assessing, and developing strategy for internal and external responses.
  • Review and author responses prior to submission to Corporate Compliance and/or regulators.
  • Track, trend, and analyze audit findings, corrective actions, and remediations; provide inputs to upstream processes for improvements.
  • Identify issues that require prompt notification and present/communicate to Olympus senior leadership in a clear and concise manner.
  • 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.
  • Develop new approaches to solve problems identified as part of the team.
  • Participate in the implementation of Global Customer Quality initiatives and programs as required.
  • Participate in the CAPA process as required as an assignee or project team member.

Requirements:

  • Bachelor's degree in a science, engineering discipline, or equivalent.
  • A minimum of 10 years of related professional experience in the medical device industry.
  • Experience in authoring 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.
  • International travel up to 25% of the time should be expected.

Preferred Qualifications:

  • Interpersonal skills to develop and manage good working relationships with all Olympus locations and internal departments (R&D, Manufacturing, Supply Chain, Regulatory, Quality, etc.).
  • Proven leadership, teamwork, collaboration, and influencing skills.
  • Ability to work effectively 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 Olympus?

At Olympus, people matter—our health, our happiness, and our lives. We offer a range of benefits to support our employees, including:

  • Competitive salaries, annual bonus, and 401(k) with company match.
  • Comprehensive Medical, Dental, Vision 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.

Language: English

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