Global Principal Auditor

vor 7 Monaten

Hamburg, Deutschland Olympus Europa SE & Co. KG (OEKG) Vollzeit

**Responsibilities**:

- 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
- 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

Your qualification
- Bachelor’s degree in Engineering discipline or equivalent
- A minimum of 7 years of related professional experience and in medical device or pharma 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 writing, reviewing, and providing feedback on audit responses, is highly valued
- Experience working in a global organization and collaborating with multiple regions / company locations
- 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 skillsSince 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.

Your competencies

Your benefits
- Flexible working hours, remote work possible (up to 60%)
- 30 days of holidays per year
- Modern office and an inspiring working environment
- Employee restaurant with live cooking and healthy food (subsidized)
- Public transport ticket (100 % subsidized) or free parking space
- Company sport groups and an inhouse company gym
- Employee Assistance Program to support your health, mental and emotional well-being
- A comprehensive company pension scheme
- Company medical officer and vaccination offers
- Bike leasing

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