Quality Manager

Location: Malmö
Reports to: Vice President R&D and Quality
Last day of application: 2019-09-30. Please apply as soon as possible as we are working continuously with the applications.

The Quality Manager is a critical hire for our business! Compliance and regulatory requirements in the life science market is becoming increasingly important, and you will have the chance be part of a company that is continuing to evolve and grow, pushing the boundaries of innovation, developing and launching new products which address unmet needs, for which there is sometimes little known regulation. This is a great opportunity for someone with a few years of relevant experience to expand on their knowledge while working for an innovative, dynamic company.

Download Job Description - Quality Manager

Contact
For questions, please contact Anna Pramhed, Vice President R&D and Quality
Phone: +46 702640588
Email: anna-pramhed@svarlifescience.com

Apply now

ABOUT YOU

The role requires knowledge and experience within Quality Assurance, Regulatory Affairs and Quality Management. The position involves managing daily activities of the Quality Team and the work is governed by regulations such as ISO13485, GLP, ISO 15189 and 21CFR820. You will lead a flexible and dedicated team with high ambitions and commitment to deliver excellent customer service and support both to our customers and different teams within Svar Life Science.

You are experienced with quality management, leading people and supporting the achievement of commercial objectives while managing risks and resources. You gain trust of your colleagues and easily build coalitions with various stakeholders, to ensure the Quality department adequately supports the other teams within the company.

You demonstrate good communications skills, social adaptability and humility. You have excellent written and verbal communication skills (in English), and can effectively communicate with both technical and non-technical audiences.

You see yourself as an integral player in quality management and can use your knowledge to deliver high standards and influence others, including corporate management, on quality matters. You have the ability to identify and evaluate improvements and benefits.

You have a strong willingness to learn and develop within the profession, with an analytical and creative problem-solving mindset.

Experience from a regulated life science industry experience is a necessity.

Responsibilities include, but are not limited to:

  • Ensuring compliance with all applicable international standards and requirements
  • Ensuring Quality Objective alignment with the business objectives and company strategy
  • Accomplishing financial objectives by forecasting requirements, preparing an annual budget, scheduling expenditures, analyzing variances etc.
  • Preparing business cases for the implementation of system investments
  • Reporting to management on quality issues, trends and effectiveness
  • Staying up to date with industry regulations/guidelines
  • Assessing impact, and securing the implementation, of updated applicable regulations
  • Managing audits and supplier/customer inspections
  • Ensuring correct communication and reporting to authorities
  • Managing and developing the Quality Management System, ensuring effectiveness and continuous improvement
  • System implementation including conversion, data reconciliation, user training, and documentation
  • Leading, organizing, and coordinating multiple work activities for, and the development of the Quality team
  • Educating and coaching employees in the quality management system
  • Participating in projects as quality representative, ensuring on-time delivery of on-budget projects with a high degree of user satisfaction and quality