QA Product Development Engineer

at  Mlnlycke

Advance performance, transform lives
Do you want a career that impacts millions of people for the good? At Mölnlycke, you’ll be helping to equip medical professionals with solutions to improve outcomes for patients. And you’ll develop your career in a growing organisation with an inspirational culture – where you’ll be recognised for the results you’ve achieved.
Mölnlycke is now looking for a new QA Product Development Engineer to join us. This position will be placed at our global HQ in Sweden, Gothenburg.

AS A QA PRODUCT DEVELOPMENT ENGINEER AT MÖLNLYCKE, THE CORE OF THE ROLE IS TO:

• Pro-actively support and advice Mölnlycke’s business areas and functions in design control and change control activities according to our quality management system (QMS)
• Support the organization in addressing quality issues that can jeopardize compliance to product development and life cycle management processes (Design Control, Change Control, Risk Management, Post Market Surveillance or related processes)
• Support the QA Process managers and process owners for product development and life cycle management processes in the implementation, maintenance and continuous improvement of the quality management system (QMS) in alignment with applicable internal and external policies, standards and regulations.

YOUR MAIN TASKS INCLUDE:

• Ensuring that Design Control, Change control and risk management processes are followed during product development projects and product changes
• Provide feedback on the applicability and adherence to QMS processes during execution of new product development projects and life cycle management activities within the areas of Design Control, Change Control, Risk Management, Post-Market surveillance and related sub-processes.
• Review, approve or reject relevant product related technical documentation for completeness and compliance according to QMS requirements and applicable regulations
• Support in root cause analysis of quality issues for design or change control, as well as giving input to effective corrections, corrective and preventive actions
• Lead smaller scale change projects
• Function as source/reference point for quality information and coach stakeholders in QMS requirements
• When applicable participate in external, corporate, and internal audit activities to support audit programs.
• Ensure right QA competence involvement at the right time in design control or change control related activities and questions