Senior Quality Assurance Manager for Medical Devices
hace 3 semanas
Solutia Life Sciences, a leading recruitment division in the pharmaceutical and biotech sectors, is seeking an experienced Senior Quality Assurance Manager to lead our medtech startup in Barcelona. With a strong commitment to delivering innovative respiratory care technology, we aim to revolutionize healthcare.
About UsWe specialize in technical and middle management profiles, providing expert solutions to clients in the medical device sector. Our team is dedicated to helping businesses scale and succeed in this highly competitive field.
Job DescriptionThis is a key role that oversees all aspects of product compliance, ensuring seamless interactions with regulatory authorities and institutions. The successful candidate will be responsible for maintaining quality management systems, developing risk management plans, and collaborating with internal and external stakeholders.
- Support QMS maintenance activities, including document control, non-conformities CAPA, change control, audits, and potential inspections.
- Develop and implement Risk Management Plans, working closely with tech partners and medical teams to ensure QA RA requirements are met.
- Prepare, review, and maintain procedures, quality plans, work instructions, forms, specifications, inspection plans, validation plans, qualification plans, templates, or any other quality document.
- Collaborate with internal and external stakeholders on identifying and documenting product-related complaints and non-conformities and developing CAPA plans.
- Investigate CAPAs and follow up with internal and external stakeholders.
- Participate in supplier qualification and approval, as well as preparation and conduct of suppliers' audits and clinical audits.
- Participate in external and internal audits and regulatory authorities' inspections.
- Support quality metrics collection, analysis, trending, and reporting.
- Maintain establishment/operating licenses and perform other duties as assigned.
To be successful in this role, you will need:
- 2-4 years of experience in QA/RA in the medical device field.
- Knowledge of ISO 13485, CE marking, and FDA applied to medical device class IIA.
- Familiarity with 'good practice' quality guidelines and regulations.
- Knowledge of Quality Assurance tasks (e.g., Auditing, Change Control, Complaints, Deviations, CAPAs, Batch Record Review, Documentation management, Training, Supplier Management, validations, qualifications, and calibrations).
- A University degree in Engineering or life-science discipline.
- Proficiency in English, both written and spoken.
€60,000 - €80,000 per annum, depending on experience.
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