Global QARA Compliance Principal Auditor

Job Description

The Global QA&RA Compliance Principal Auditor will be responsible for the support of the Global QMS Internal Audit Process and execution of global internal audits. Will lead Quality System audits throughout the organization to assess compliance of the quality system to applicable regulations, standards, and internal requirements. Serves as auditing subject matter expert and provide guidance on the interpretation of applicable regulations and standards. Will collaborate with stakeholders and partners to support the development and execution of a global internal audit program and supporting tools / resources that enhance internal audit capabilities.

Job Duties

* Lead quality system audits throughout the global organization and all company locations that provide assurance of the compliance and effectiveness of the quality system.

* Supports the establishment of a global internal audit program and execution of internal audit schedules.

* Support the development and delivery of internal audit training activities throughout the organization.

* Coordinate and support requests for directed audits, received from senior management and other customer/business partners.

* Serves as an Expert on applicable regulatory requirements, their interpretation, and application.

* Support external inspections and audit management for various sites, which will include site inspection/audit readiness and execution, as needed.

* Lead or support special quality and compliance projects as requested, and perform other assigned duties, as needed.

Job Requirements

REQUIRED QUALIFICATIONS:

* Bachelor’s degree in Engineering discipline or equivalent.

* A minimum of 7 years of related professional experience and in medical device industry.

* A minimum of 5 years experience of auditing quality systems in a medical device environment is required.

* 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 working in a global organization and collaborating with multiple regions / company locations.

* 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 60 % of the time should be expected.

PREFERRED QUALIFICATIONS:

* Experience writing, reviewing, and providing feedback on audit responses, is highly valued.

* 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 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 Japanese and / or English language (desired but not required).

** The anticipated compensation range for this position is $88,000 to $124,000 USD annually and the compensation offered will depend on the candidate’s qualifications.