Do you want to enjoy what you do – for real – every day? If the answer is yes, you think just like us. In our daily work, we create unique medical solutions to improve quality of life. We enjoy what we do because it makes a difference in people’s lives – for real. Mölnlycke is a world leading supplier of disposable products and solutions that help healthcare professionals achieve the best patient-related, clinical and financial outcomes. We design and deliver products and solutions for wound care, pressure ulcer prevention and surgery. Our products and solutions are cost-effective, which is supported by both clinical and health economic evidence.
We are now recruiting a Global Product Complaints Specialist
The purpose of the role is to ensure patient safety by providing a comprehensive and effective product complaint handling and incident reporting.
This will be achieved by working closely with QA and RA management to
- secure compliance with internal and external requirements for Medical Devices and Pharmaceuticals.
- handle customer feedback in a satisfying and proactive way.
- address necessary corrective and preventive actions.
The role will also, together with the Global Product Complaints Manager, drive as well as develop the vigilance, pharmacovigilance and product complaints handling competence within the entire Mölnlycke health Care organisation.
- Responsible for daily management and prioritization of product complaints handling.
- Responsible for incident reporting – to compile and provide reports to authorities concerning complaints.
- Interact with external stakeholders e.g. Competent Authorities and Notified Bodies regarding incident reporting and other product quality issues.
- Develop and provide relevant training for all staff, but most importantly to local complaint handlers, QA managers and complaint coordinators.
- Together with Product Complaints process owner improve existing applicable processes and/or developing of new processes.
- Review change requests and procedures related to product complaints and incident reporting.
- Directly and frequently communicate and interact with internal stakeholders within Clinical, QA/RA, R&D, Operations and Commercial organization.
- Pro-actively contribute to the Post Market Surveillance process.
- If required represent the Global Product Complaints team and actively participate in internal and external audits/inspections. Contribute to progress and closure of corrective actions.
- Academic background in life sciences, chemistry, quality management or regulatory affairs
- Experience from work in an international environment.
- Background in medical devices and/or pharmaceuticals with post-marketing surveillance, complaints handling and/or voice of customer experience.
- Experience of Medical Device Vigilance principles and regulations
- A clinical background and technical/product knowledge would be advantageous.
The successful applicant is a positive team player with a high degree of customer focus and with a results oriented mindset. You have an eye for details, analytical/problem solving skills and strong decision-making skills taking responsibility for your actions. Excellent communication and networking skills are required due to the high extent of internal as well as external contacts.
Selection and interviews are held continuously so please send your CV and cover letter as soon as possible to firstname.lastname@example.org and no later than 31 March 2018.
Questions regarding this position: contact Tom Bergqvist, In-house Recruitment Partner at +46 (0)733 – 872722.
”Genom att skicka din ansökan ger du också ditt samtycke till att vi lagrar dina personuppgifter, inklusive CV & personligt brev samt att vi äger rättigheten att dela dessa uppgifter med tredje part (vår uppdragsgivare). Samtycket kan du återkalla när du vill.”