Quality Assurance Manager Medtech - Swemac Innovation AB

Swemac Innovation AB specializes in medical technology, focusing on the development of high-quality orthopaedic implants and instruments for fracture treatment and prosthetic surgery. Our ambition is to be a leading global company, consistently delivering innovative and practical solutions for both patients and healthcare professionals. The Swemac group manages its own sales operations in the Nordic region, while products are distributed globally through distribution channels. We have a presence in Sweden, Norway, Denmark, Germany, United Kingdom and Japan, with our headquarters based in Linköping. Currently, our global team consists of 100 dedicated employees, contributing to a group turnover of around SEK 300 million. Explore more about us at www.swemac.com.

Do you have experience in quality management, ISO 13485 and medical devices?

We are now seeking a Quality Assurance Manager to strengthen our quality department in Linköping. Our Quality team ensures the delivery of safe, effective and compliant medical devices to patients worldwide, working closely with our colleagues in Regulatory Affairs, R&D and Operations.

Your role
As our Quality Assurance Manager you have substantial experience in quality work within the medical device industry, or a similar industry subject to strict regulatory requirements like; Pharmaceuticals, In vitro diagnostics or Aeronautics. You will be responsible for/managing all aspects of the work related to the Quality Management System, Quality process and related processes. You will lead the quality team in both functional and cross-functional quality improvement activities to ensure compliance with requirements and regulations. Continuously communicating and providing training and giving advice in relevant areas are also a big part of the role. Further you will lead or contribute to the planning, execution and coordination of quality activities throughout the Swemac group including subsidiaries in Germany, Denmark and Japan.

Your responsibilities

• Lead and develop the Quality team
• Lead and develop the Quality work at Swemac
• Development of our Quality Management System in accordance with ISO 13485, MDR and QSR
• Manage external audits from Notified body and Competent Authorities
• Manage internal quality audits and supplier audits
• Non-conformity handling and CAPA management
• Creation of QM documentation and process documentation
• Support the organization in Quality related issues
• Participation in or implementation of various activities in the area of quality and change management

Your qualifications

• Relevant degree, bachelor or higher, with experience (5+ years) of working within Quality in a regulated business
• Analytical and data-driven attitude with a solution-oriented working style
• Knowledge of ISO 13485, 93/42 EEC, 2017/745 MDR is an advantage
• Excellent communicator with experience in leading teams and people management
• Knowledge of the standards ISO 14971, ISO 10993-1, ISO 17664 and ISO 11135 is an advantage
• Demonstrate drive and energy to make a difference as well as demonstrate a high degree of flexibility
• High sense of quality, personal credibility and responsibility
• Very good organizational and administrative skills
• Excellent proficiency in Swedish and English, both spoken and written

We highly value your personal qualities and are looking for a colleague who is self-motivated and resourceful with strong initiative while also excelling in building strong relationships and collaborating with other teams, in an inclusive environment.

What you can expect
We offer an interesting and stimulating position in an innovative and international environment where attention to quality is central to our development and production. The company culture is open and dynamic, and the organizational structure is flat. The placement is at the head office in Linköping, and we are located in modern facilities at Mjärdevi Science Park. The position offers the possibility of hybrid work. The position is full-time, permanent employment with the start date to be agreed upon.

Application
Swemac Innovation AB collaborates in this recruitment with Cojn Executive AB and if you have any questions, please contact recruitment consultant Caroline Hansson + 46 76-850 11 70. We look forward to your application with an updated CV and a cover letter as soon as possible, last day to apply is 10th of March 2024.