QA Manager – Product Development

Are you passionate about making life better for patients worldwide?

If the answer is yes, you think just like us. We are a world-leading medical solutions company, designing and supplying medical solutions to enhance performance in healthcare – from the hospital to the home.

We’re looking for QA Manager – Product Development, to help improve outcomes for healthcare professionals and their patients.

QA Manager – Product Development

In this role you provide leadership to the Product Development QA Engineers in tasks related to compliance status for product technical documentation. Through stakeholder engagement, people development, guidance, education, coaching, supporting, directing, and evolution;

• of the product’s technical documentation
• of the applicability and execution in accordance with the QMS processes within product development and life cycle management processes owned by the QA product development team

this role produces continuous and sustainable improvements to our time-to­ market, doing it right the first time leading to decreasing post market interventions

Key Accountabilities

• Secure QA resource needs for New Product Development (NPD) and Life Cycle Management (LCM) activities
• Assure alignment and teamwork between RA and QA in new product development or product change activities
• Manager responsibilities for defined team members
• Ensure the proper QA competence involvement at the right time in design control or change control related activities and questions
• Support the QA process managers and process owners 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
• Develop and maintain relevant quality metrics
• Participate in external, corporate, local or any internal audit activities to support audit programs
• Act as QA Product Development engineer in New Product Development projects and Life Cycle Management activities if needed

Qualifications & Experience 

• Working experience from medical device industry, pharmaceuticals, or potentially other highly regulated industry
• Several years’ experience from R&D/Product Development and/or Quality Assurance
• Proven leadership skills – to coach, develop and lead the team
• Strong in building cross-functional relationships, and stakeholder management
• Ability/Skills to support audits and inspections
• Good communication skills, fluent in English and preferably, but not mandatory, Swedish

To apply

We are looking forward to receiving your application as soon as possible. For more information about Mölnlycke, the role and to apply, please contact Tom Bergqvist, Moveup Consulting AB, 0733 – 87 27 22.

Applications must be sent by e-mail to: tom.bergqvist@moveup.se

By submitting your application, you also give your consent to storing your personal information, including CV & Cover letter, and that we own the right to share this information with third parties (our client). You can withdraw the consent at any time.