Senior Manager Customer Quality Compliance Operations

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

The position leads cross-functional team to investigate and develop responses to internal and external audit findings and observations, including3rd party and regulator audits. The position 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, and will also provide routine progress updates and escalation of potential compliance issues to functional and site leadership respectively. The position will provide guidance, training, and coaching to team on quality compliance matters including on communication during audits and in responses.

Job Duties

• Implements and maintains the Customer Quality external and internal audit response process and activities.
• Monitors for timely completion of applicable Customer Quality commitments to US FDA, and other Regulatory Authorities as applicable.
• Leads cross site / functional teams on investigating, assessing, and developing strategy for internal and external responses.
• Reviews and authors responses prior to submission to Corporate Compliance and/or regulators
• Tracks, trends, and analyzes audit findings, corrective actions, and remediations; provide inputs to upstream processes for improvements.
• Identifies issues that require prompt notification and presents/communicates to Olympus senior leadership in a clear and concise manner.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Advises 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 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 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.
• Since this is a Global Rol