Compliance Auditor - Hamburg, Deutschland - Jobijoba-de

Beschreibung

Global Principal Auditor (m/f/d)

Quality and Regulatory Compliance Olympus Europa SE & Co. KG (OEKG) | Medical Systems Type of employment:
Permanent employment Function: Quality / Audit /

Corporate Governance Location:
Hamburg (hybrid model)

Reference Number:
Website:Your 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
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
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 skills

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 30-50 % of the time should be expected.
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
About Olympus Medical Systems
Olympus is passionate about creating customer-driven solutions for the medical, life sciences, and industrial equipment industries.

For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling by helping to detect, prevent, and treat disease; furthering scientific research; and ensuring public safety.

As a leading medical technology company, our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients and their safety.

Olympus' Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications.

More reasons to join our team