Quality Assurance Specialist

Every day, Getinge Group enables healthcare professionals to save lives. Based on first-hand experience and close partnerships, we provide innovative healthcare solutions to support before, during and after the patients’ hospital stay. Our company is built on a genuine compassion for people’s health and well-being. We approach our work with passion. In addition, our culture and behavior are guided by collaboration, openness, ownership and excellence – values we believe are the key to our success. Being part of Getinge Group means being an ambassador for these values and contributing to making a difference in peoples’ lives.

We are recruiting a Quality Assurance Specialist for Getinge Sterilization AB, which is part of Getinge group, center of excellence for sterilization. We develop and manufacture units sold worldwide for the healthcare sector as well as highly customized units for the BioPharma and BioMedical sector. Getinge Group is in an exciting and intensive period of change and you will be a key player when it comes to ensuring compliance to regulations, global and local internal requirements and improvement initiatives. This position offers you a great opportunity to be part of an exciting journey, to contribute by making a difference. We are in a process to share common procedures globally and being integrated into a global Quality organization.

The position

The primary purpose of this role is to ensure timely handling of Customer Complaints Investigations in cooperation with the global team for Complaint handling. You will be the Quality department representative towards the local organization with technical experts and the coordinator in the communication with the global team regarding Product Quality.

Your main responsibilities and tasks will be:
Product Safety coordination:
•Lead Product Safety Committee
•Local customer complaint support and authority reporting for Life Science
•Local Field Actions coordination
•Customer complaint related warranty handling

CAPA coordination:
•Coordinate, monitor and follow up of on-going CAPA including KPI reporting
•Prepare and lead CAPA board meetings
•Support CAPA owners on process and activities

Post Market Surveillance coordination:
•Coordinate, monitor and follow up on Post Market Surveillance activities

IT Validation:
•Coordinate, monitor and follow up on IT system and tool validation activities as planning of periodic reviews, perform evaluation of validation needs etc.

The position is located in Getinge, Halmstad. The position reports directly to the Quality Manager for the site. The position will be open for personal development and future responsibilities such as Process Ownership within the QA organization.

The ideal candidate

As ideal for the position you have the following key characteristics:
•Bachelor’s degree in science, quality, engineering or similar
•Minimum 3 years’ experience working within Quality Department in the Medical device industry
•High knowledge and experience from coordination, monitoring and follow up in areas such as CAPA, Field Safety Correction Actions and Post Market Surveillance
•Knowledge and/or experience from IT-system validation is beneficial
•Successful interactions and communication skills with all levels of the organization providing direction and support
•Experience from Internal Audits
•Good knowledge of Quality Management Systems (e.g. ISO 9001, ISO 13485 and ISO 14001)
•Fluently spoken and written Swedish and English is necessary

As a person you are a collaborative team-player with high integrity and good communications skills. You have a structured personality and make sure actions are implemented.

Application

Are you interested in becoming part of an international and market leading medical technology company whose products a make huge difference for patients, healthcare professionals and societies all around the world? Getinge offers a great opportunity to make a difference in a global and dynamic environment!

Welcome with your application no later than 17th of February if you are interested in the position. You are also welcome to contact Pia Brorson at +46 (0)10 335 5910 if you have questions.
Background checks may be carried out.

Getinge Group is a leading global provider of innovative solutions for operating rooms, intensive-care units, hospital wards, sterilization departments, elderly care and for life science companies and institutions. With a genuine passion for life, we build quality and safety into every system.

Our unique value proposition mirrors the continuum of care, enhancing efficiency throughout the clinical pathway. Based on our first-hand experience and close partnerships, we are able to exceed expectations from customers – improving the every-day life for people, today and tomorrow.
We employ around 16,000 talented employees across the globe and generate annual sales of about SEK 30 billion.