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 broadening the business and have high ambitions for the future. Do you want to be part of this exciting journey as our Global SQA Manager Raw Materials and Components?
As a Global SQA Manager, you lead and manage the Supplier Quality Assurance department dedicated to Raw materials and Components. You ensure that robust processes are in place by simplifying and harmonizing procedures globally, identifying gaps and remediating plans when necessary. You qualify the suppliers according to internal requirements and applicable standards and regulations. You continuously evaluate their performance by implementing indicators.
Your key accountabilities
- Maintain the approved supplier list up to date with the defined criteria as per procedures in place
- Develop and sign Quality Agreements with the suppliers to define role and responsibilities and process to follow such as (not limited to) : CAPA, risk analysis process, regulatory requirements and complaints management process.
- Continuously evaluate suppliers’ performance (scoring) and work on a continuous improvements programs with suppliers including complaints follow up.
- Develop a yearly Global Audit plan in collaboration with the manufacturing sites.
- Discuss and review the suppliers’ validation plan with the Design and Validation QA manager to comply with internal and external requirements.
- Define documents to be provided by the suppliers when shipping products, and plan any additional tests to be performed when necessary before release. Define attributes for final release of the raw materials and components.
- Review and approve specifications developed for materials and components to be purchased.
- Follow up complaints related to raw materials and components, and involve manufacturing sites when necessary.
- Organize Quality Quarterly review, complaints/CAPA review, manufacturing KPIs etc. for key suppliers.
- Support manufacturing sites regarding Raw Materials and Components approval processes.
- Implement Training requirements for SQA RM & Components team and develop training programs for cross functional team.
- Relevant degree in Science or Engineering.
- A minimum of 5 years in similar role in an established Quality function with significant expertise in supplier management and/or validation.
- Experience from pharma or medical devices would be considered advantageous (MDD/FDA, standards such as EN13795, ISO10993, ISO11607, ISO/9901/ISO13485/GMP experience).
- Fluent in English.
- Excellent interpersonal, communication, facilitation and team working skills, adaptable and flexible.
- Project management skils.
You report to QA Director Operations and Supply. This is a full time permanent position based in Gothenburg (Sweden) or Waremme (Belgium).
Closing date for applications is 30 June. Please send your CV and cover letter to email@example.com
Please contact Tom Bergqvist, Recruitment Partner, In-house Recruitment Services at +46 733 87 27 22 if you have any questions regarding this position.
We look forward to receiving your application.