Specialist, Internal Audits
The Quality Assurance department in Denmark is looking for a new colleague for their Quality System Audits team who is working with various aspects of Quality Assurance of medical devices.
We have an informal environment and are working together with experienced colleagues in-house as well as with colleagues of Cook Medical companies based worldwide.
Your main responsibilities as a Quality System Audits Specialist will be:
• Performing Internal audits
• Oversight of regulatory compliance within the Quality Management System
• Following up on findings from internal audits
• Maintaining expertise within applicable standards and regulations
• Supporting the organization in relation to the Quality Management System
• Supporting the organization during external audits when needed
The following qualifications will be appreciated, but not required:
- A scientific educational background, e.g., a degree in Life Science, Pharmaceutical Science, Engineering or other relevant background
- 3 years+ of hands-on Quality Assurance experience – preferably within the medical device industry
- Knowledge of applicable standards and regulatory requirements for medical devices (ISO 13485, MDD 93/42/EEC and FDA 21 CFR, Part 820)
- Auditor experience
- Excellent verbal and written communication skills in English and Danish
- Excellent communication and interpersonal skills at all levels
- Demonstrable computer skills
You have an eye for detail and the ability to multitask and prioritize work in a thorough and systematic way.
You work independently within your own areas of responsibility but more importantly, we expect you to be a great team player with a positive and committed approach to your assignments.
Cook Medical has a healthy company culture with a strong common set of values. Responsible, competent and professional employees are our most important resource. We have a flat organizational structure and focus on open dialogue. Qualities such as determination, loyalty and humour are highly appreciated.
Cook Medical's employees help uphold the company’s philosophy of developing innovative medical solutions to raise the quality of patient treatment worldwide - every day, we make a difference.
Cook Medical offers a well-organized internal training course to all new employees to enable them to quickly gain thorough knowledge of the company.
In addition to a salary package with pension, we offer flex time, a bonus system, health insurance, as well as free use of the company’s own gym.
For further information about the job, please feel free to contact Simon Bjørn Larsen, Manager, Quality System Audits, by phone: +45 20 80 52 83 or e-mail: email@example.com.
Deadline for applications is March 24, 2019