Work Schedule

Environmental Conditions

Job Description

The Sr. Manager, QA Release oversees and directs the QA Release team and is responsible for planning of the daily operations for the activities within the area.

The Team Manager, QA Release also reports to this position.

This position assure that acceptance activities are performed in a timely manner; with patient, customer and safety in focus and ensures compliance with external requirements and efficiency of the processes for Acceptance and Release and Non-conformities.

The position is based in Uppsala, Sweden and reports to the Director of Global Quality Assurance and serves as a key business partner, working cross-functionally to support the business.

Main responsibilities:

Manager for the QA Release team

Lead, staff and organize the QA Release team to achieve agreed targets and important metric:s.

Responsible for defining targets and important metric:s for the team

Responsible for the team budget

Develop the teams´ operations with respect to capacity, working methods, competence, personnel, and organization.

Assure QSR, ISO and IDD's business system, as applicable quality policy and quality manual, are followed.

Manage the Non-conformity process

Manage the Acceptance and Release process.

Responsibility for the process for approval of Specification & Acceptance Criteria.

Participate in preparations and participate in internal and external audits.

Participates in team projects and assignments, facilitating or leading teams as necessary.

Identifies the opportunities for continuous improvement of the Quality Systems.

Provide Quality System expertise to the organization and ensure compliance to applicable Quality System Regulations by supporting interpretation of regulations, performing gap analysis and lead activities to implement improvements.

Support investigations, and resolve Quality System non-conformities (defined during internal and/or external audits).

Train personnel on Quality Management System related topics.

Qualifications/Requirements for position

University degree in medical/technical sciences or equivalent work experience.

Minimum of 5 years in a medical regulated industry with experience in a management position, including personnel responsibilities.

Experience in working with quality management systems in an IVD/Medical device environment.

Knowledge in working with quality management systems in an IVD/Medical device environment (e.g. QSR, EU medical directive, ISO 13485, ISO14971).

Experience in analyze and interpretation of regulations, directives and standards.

Excellent verbal/written communication skills in English are required.

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.

Experience in QA Release is meritorious.

Please apply via our internal career site!