Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

We are hiring a Sr Manager, Quality Systems and Supplier Quality to join our team in Uppsala. Our focus is on developing, manufacturing, and selling blood test systems for clinical diagnosis and monitoring of allergy, asthma, and autoimmune diseases. We're the global leader in in-vitro allergy testing and the top European company for autoimmunity diagnostics. With 1,900 employees worldwide, 1,000 of which are in Sweden, we're proud to be at the forefront of this field.

As the Sr. Manager you will lead all aspects of and direct the Quality Systems and Supplier Quality team and you are also responsible for planning of the daily operations for the activities related to Quality System improvements, Document Control, Change Control, Internal and supplier audits, Supplier Quality and Quality related IT-systems.

• Lead the team, in close and active collaboration with other teams within in the function and other functions such as R&D and Operations.
• Ensure global compliance with medical device and in vitro diagnostic Quality System regulations, directives and standards.
• Provide Quality System expertise to the organization and ensure compliance to ISO 13485, EU IVDR, QSR and other applicable requirements by supporting interpretation of regulations, lead gap analysis and activities to implement improvements.
• Interface, as needed, with agencies, Notified Bodies and professional organizations to verify that divisional and departmental Quality Systems remain current and efficient.
• Assure compliant and efficient processes for Supplier Quality Assurance.
• Interface cross-functionally to resolve supplier related quality issues.
• Develop and maintain the functional strategic roadmap for renewal of the Quality System and related IT systems for effective operation.
• Drive the Quality Management System harmonization between sites within the division.
• Establish, organize and supervise the annual Quality Plan improvement efforts
• Write, change and update the Quality Manual and Quality procedures as applicable.
• Lead and/or participate in the completion and maintenance of risk analysis for quality systems.
• Lead preparations for and participate in external audits.
• Assure investigation and resolution of Quality System non-conformities from external audits.
• Assure accurate communication and company-wide Quality trainings.
• Assure that the audit programs are efficient.

• Minimum of 10 years preferred in a medical regulated industry with experience in a management position, including personnel responsibilities.
• Significant experience in working with Quality Management Systems in an IVD/Medical device environment. (e.g. QSR, EU IVDR, ISO 13485, ISO14971).
• Experience in Supplier Quality.
• Experience in analyzing and interpreting regulations and standards.
• Coaching Leadership style with ability to set clear direction and delegate authority.
• Being a role model leader in developing and motivating people at all levels.
• Ability to create a strong quality culture, fostering integrity.
• Strong social skills, driving cross-functional collaboration
• Strong ability to drive tasks/projects to closure in a timely fashion
• Excellent verbal/written communication skills in English and Swedish.

• We offer driven remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits!
• We offer employment with an innovative, forward-thinking organization, and outstanding career and development prospects.