…a unique chance to play a key role in the further development and growth of the company.
Contura International A/S, is looking for a highly competent and experienced Quality Assurance Director. Contura International – is a Copenhagen based medical technology company that develops, manufactures and commercializes soft tissue fillers based on proprietary hydrogel technology. The facility, which is approved in US, Europe, Canada, Australia, etc., is designed to fulfil global regulatory requirements and deliver Contura’s entire range of hydrogel products. Contura has recently obtained FDA approval for its product for treating stress urinary incontinence in women, Bulkamid®, and a manufacturing license (§39) for production of its hydrogel technology as a medicinal product.
The company’s development, manufacturing and testing processes comply with the European Medical Devices directive 93/42/EEC and the quality system meets the standards required to obtain ISO 13485:2016.
This is the company – and this is the position – where the new quality assurance director will get a unique chance to play a key role in the further development and growth of the company.
The Company Offers:
A challenging position in a company with dedicated people and a strong pioneer spirit.
They reach the objectives through an interdisciplinary collaboration between motivated and competent colleagues in an informal working environment.
There is a natural focus on the ongoing development of your professional and personal skills that will help to ensure the company’s continued success in an ever more demanding area of the medical device industry.
As Quality Assurance Director, you will report to the Managing Director and work closely with colleagues from other functions, national as well as international.
As management representative you will be responsible for development and maintenance of the Quality system, including quality assurance of products and manufacturing processes.
You will directly manage 1 competent employee and work closely together with the RA Director.
Your key responsibilities include but are not limited to:
- Conduct transfer from MDD to MDR
- Upgrade and maintain the Quality System
- Review and approve relevant GMP documentation
- Conduct product releases
- Conduct and participate in audits
- Handle contact to Competent Authorities, Notified Body, FDA and other relevant authorities in connection with the QMS and product vigilance
- Manager for the department including ensuring relevant training as well as development of necessary competences
- You have a master´s degree in a relevant natural science and you have a minimum of five (5) years’ experience preferable from Medtech and or the pharmaceutical industry
- You have a minimum of five (5) years’ experience in a Quality function.
- You have experience with:
- Operational QC/QA activities for medical devices in Europe, US and worldwide.
- European Medical Device Directive (MDD), ISO 13485 as well as US medical device regulations (CFR 21 part 820)
- You have extensive GMP knowledge and experience from production site
- You have experience with product vigilance
- Preferably management / project management experience
- Besides you have strong communication skills in Danish and English
- Ability to handle multiple tasks and meet agreed deadlines
- Ability to work intensively in teams and with external parties while maintaining independence and integrity
- Open minded and enjoy team work with colleagues from other disciplines
- Receptive to new opportunities and sustainable solutions.
- Professionally experienced and agile.
Application and further information:
If you would like additional information about this position before applying using the link, please contact Hanne Beirholm, Beirholm Search. Tel. +4529440080 /mail: firstname.lastname@example.org