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Do you want to have a career where you make a difference and save lives? Do you want to improve healthcare outcomes around the world? We are looking for a driven R&D Process Specialist with an analytical mindset and coaching approach to join our exciting journey.
Are you ready for your next challenge?
As a R&D Process Specialist you will be responsible for integrity and compliance status of agreed R&D core processes in accordance with external quality and regulatory requirements and with other aspects of the Mölnlycke quality management system. You will work with all aspects of our core R&D processes like Design Control but with a main focus on Risk Management and Usability Engineering for the global R&D community.
You will be part of a truly global team where we encourage and listen to each other. In this role you will produce sustainable improvements to our time-to-market and contribute to the company´s growth and strategic goals through stakeholder engagement, people development, education, coaching, and evolution of defined R&D processes and tools.
- Provide strategic guidance for defined R&D processes throughout the product lifecycle.
- Develop and maintain processes and related QMS documentation for defined R&D processes and provide training to stakeholders.
- Support in identifying and evaluating new or changed regulatory requirements related to defined R&D processes, conduct impact assessments, prepare implementation plans as required, including user training.
- Support in providing an effective continuous training plan and support structure for defined R&D processes.
- Support in anticipating regulatory/compliance risks related to defined R&D processes and provide solutions for risk mitigation throughout the product lifecycle.
- Support in ensuring R&D audit and inspection readiness for defined R&D processes.
- Support teams in audit and inspection activities.
- Academic background in Engineering or Life Sciences (Bachelor or Master Degree) or corresponding experience.
- Minimum 5 years of experience from medical device industry or equivalent.
- Experience in Design Control related to medical devices (e.g. ISO 13485 / CFR part 820) and Risk Management (e.g. ISO 14971) and Usability Engineering.
- Leader skills in order to coach and develop the R&D staff in general.
- Good communication skills.
- An interest in developing others and driving improvements.
- Excellent English written and spoken.
If you feel you have the right skills to offer for this position or would be interested in other positions with Molnlycke then please email [email protected] with your CV or apply through LinkedIn https://www.linkedin.com/jobs/view/1959943167/