Quality Supplier Specialist

Do you want to make a difference by developing key lifesaving medical device products? In a truly global business who refuse to compromise when it comes to caring for people.
You will be part of a QA team that today consists of fourteen people with different background and experience. The team is responsible for quality assurance and quality development activities within the core processes Supply Chain Management and Product Lifecycle Management. This includes QA expertise during product development, production and further development of the already released products and manufacturing processes, handling of non-conformities as well as the qualification, auditing and monitoring of suppliers.
As a QA Supplier Specialist you will work in a cross functional team mainly with Purchasing, and with regular contacts with Production, R&D and Marketing and provide QA expertise and guidance to ensure safe, reliable and compliant components from qualified suppliers. You will manage the documentation of the supplier qualification process as well as re-qualifications. In this position you will also plan and perform supplier audits according to internal requirements.
We offer you an exciting possibility to join our fantastic team creating tomorrow’s solutions for Point of Care testing making peoples life’s better.
Responsibilities
Ensure that activities, within supplier management are in compliance with applicable requirements such as ISO 13485, QSR and MDSAP as well as industry standard
Maintain and ensure compliance to the supplier management procedures and internal requirements (qualifications, re-qualifications, monitoring and audits)
Active participation in weekly Procurement Review Boards
Present the supplier management process including supplier records at internal and external audits

Qualifications
To qualify for the position, you need University degree in science or technology or documented experience from a similar position.
We also believe that a candidate has the following profile:
Minimum five years of experience from a QA position from the Medical Device Industry or similar including experience in performing audits
Strong communication skills and can motivate and inspire your colleagues, even when there are conflicting demands
Ability to understand medical device regulations and standards. It is an advantage if you have knowledge and are trained in relevant standards and regulations, QSR, ISO 13485, ISO 14971, MDSAP
Fluent in English and Swedish in writing and speaking

Personality
To succeed as a QA Supplier Specialist you need to be systematic and organized, you also need to value and enjoy good teamwork. Furthermore, we believe that a can-do attitude and ability to prioritize in a fast paced environment is key. You also enjoy working in a company that aims to continuously improve, both in terms of equipment and processes.
Interviews will be held as soon as relevant candidates have been identified
Send your application via www.hemocue.com/careers. We are not able to receive your application by other means than through “careers“. Any application by mail or e-mail will be returned.
We offer you
A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combined makes it both fun and meaningful to go to work. You will meet enthusiastic colleagues in both Sweden and abroad who take pride in making a difference in a company whose products can truly impact other people's lives. We offer you 'freedom with responsibility', opportunities for training and career development.
The position is a full-time position with flexible location. We can offer you an office space in either our head office in Ängelholm or in our brand-new satellite office in Lund.
We are looking forward to receiving your application no later than December 12, 2021.
For further information, please contact Manager QA Operations, Björn Bylander +46 431 48 12 87.
Union contacts: Henrik Pommer, Unionen +46 431 48 12 44 or Elin Söderlind, Akademikerföreningen, +46 431 48 12 62.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
If you’ve ever wondered what’s within you, there’s no better time to find out.