Senior Manager, Customer Quality Emerging Issues

Job Description

The position gathers, collates, maintains, and distributes Emerging Issues list by soliciting input from ship hold, HHA, FCA, regulatory affairs, compliant handling, and product quality teams.

The position will present and communicate Emerging Issus to executive leadership and escalate any issues that require prompt resolution.

The position will track and where needed, facilitate cross-functional team to investigate and develop action plans to resolve the product issue.

The position will review and author responses to requests for additional information from FDA and other regulators on post market topics.

The position will ensure adequate tracking and monitoring of AIRs to facilitate timely implementation and completion of actions, and will also provide routine progress updates.

Job Duties

• Gathers, collates, and maintains Emerging Issues report; distributes and presents to internal stakeholders.
• Responsible for the completion of regulator requests for additional information to the US FDA, and otherRegulatory Authorities as applicable.
• Facilitates cross functional teams on investigating, assessing and authoring responses.
• Tracks, trends, and analyzes requests for additional information from regulators, respective corrective actions,and remediation.
• 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.
• Sends leadership urgent or escalated product issue notifications.
• 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 10 years of related professional experience in the medical device industry.
• 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.
• Experience working with, presenting, and communicating with executive leadership.
• Experience with implementing tracking and monitoring tools.
• Fluent in English language
• 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 :

• Experience in authoring and managing communications with regulatory agencies preferred.
• Experience in problem solving, root cause analysis, and CAPA 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 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.

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
30+ days ago