Senior Engineer QARA Global External Audit Support

Working Location: MASSACHUSETTS, WESTBOROUGH 

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.

Job Description

Provides support to ensure compliance of the Global Quality System with applicable regulatory requirements and the business strategy of the company. Represents Global QA&RA Compliance as a team member and leads/supports the development and implementation of the Global external audit process, programs, and activities specific to communications. Supports the development of global regulatory communication processes to include responses to external audits as well as routine information requests from regulatory agencies. Member of a Global Audit Support Function established as a dedicated team to implementing the Global External Audit Process, provides all Olympus sites support for external audits, improving outcomes and efficiencies. Supports compliance response communications (VAI, OAI etc.) with regulatory agencies as well as fulfilling routine requests for information with regulatory agencies such as RFAIs.

Job Duties

• Responsible/supports the development and implementation of the Global external audit process, programs, and activities.
• Participates in the development of process and procedure development/changes.
• Responsible/supports for the development of external audit responses, facilitates completion, and delivery of responses to the US FDA, Notified Bodies, and other authorities as required. Supports the development and implementation of global audit response processes. · Provides support for completing and submitting regulatory compliance requests for information to the US FDA, Notified Bodies, and other authorities.
• Supports the development and delivery of Global QA&RA organizational communications.
• Responsible/supports the development and implementation of new monitoring and reporting tools that measure progress of external audit schedules and audit outcomes. Identifies, accesses, and analyses data that have impact on the company’s compliance to overall quality systems. Tracks, trends, and analyses external audit findings, corrective actions, and remediations. Make recommendations based on areas of highest compliance risk.
• Supports the maintenance of the Olympus Site Compliance Risk Assessment.
• Participant in Global External Audit Communities of Practice.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Supports the development of innovative approaches to solve problems identified as part of the team. Assist in the implementation of Global QA&RA Compliance initiatives and programs throughout the Global organization.
• Participates in the CAPA process as required as an assignee or project team member.

Job Qualifications

Required:

• Bachelor’s degree in engineering discipline or equivalent
• Minimum of 5 years related experience in 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.
• Very strong risk/auditor skills – critical to evaluate remediation of issues and management’s action plans.
•  Direct experience in US FDA, Notified Body, and other International Regulatory Agency Audits. Experience with supporting sites with regulatory audits.
• Experience writing, reviewing, and providing feedback on audit responses to regulatory authorities specifically FDA, is required. Experience with managing and submitting regulatory agency requests for compliance information is preferable.
• Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones.
• Domestic and international travel up to 40 % of the time should be expected.

Why join Olympus?

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

• Competitive salaries, annual bonus and 401(k)* with company match
• Compre