Senior Production Quality Assurance Associate

Regulatory Affairs & Quality Assurance        ·       Barcelona, Spain        ·       Full time / Permanent

About the job

Position Summary

The Senior Production Quality Assurance Associate will participate in the development and implementation of procedures and other quality related documentation for the production activities, ensures that the activities are performed according to the quality system and cGMP, ensures that documentation related to the production of the devices is prepared and stored according to the established procedures and quality standards. The SPQA Associate works closely with the Production department and serves as a subject matter expert for production quality matters.

Main Responsibilities

• Responsible for the development and implementation of quality aspects to ensure that production operations (from supplier qualifications to delivery of the products to clients) are in compliance with cGMP and other regulatory requirements.
• Participate in preparing and reviewing procedures, work instructions, forms, specifications, inspections plans, validation plans, qualification plans, etc…
• Ensure that all documentation related to devices production is prepared and available, reviewed, approved, stored and applied as per the QMS requirements.
• Ensure compliance of batch documentation. Review production batch records. Perform batch release according to internal procedures.
• Work on the identification and documentation of product related complaints, nonconformities, development of CAPA plans, with both internal and external stakeholders.
• Support the collection, analyzing, trending, and reporting out on quality metrics
• Oversee the Change control activities related to production activities are properly planned, documented, and implemented.
• Prepare and perform/oversee the performance of suppliers’ audits according to the internal procedures and quality agreements in place.
• Participate in external and internal audits and regulatory authorities’ inspections
• Support in Risk management activities (PFMEA)
• Work with all relevant internal stakeholders including production, supply chain, product development/engineering teams, regulatory affairs, quality etc… to ensure compliance and continuous improvement.
• Recommend and implement process improvements to internal activities and procedures as indicated by customer claims, non-conformities , audit observations, new regulations, guidance documents and industry standards
• Act as the Person Responsible for Regulatory Compliance (PRRC)

Experience And Education

• 4 years’ of quality and GMP experience working in a medical device, (preferred) pharmaceutical or biotechnology company
• Degree in Engineering or related technical field

Values and Attributes

• Strong organizational and interpersonal skills
• Strong written and oral communications skills (English, Spanish)
• Detail oriented
• Able to manage multiple projects with shifting priorities

Required Training And Skills

• Expert in Quality Assurance tasks (e.g., Auditing, Change Control, Complaints, Deviations, CAPAs, Batch Record review, Documentation management, Training, Supplier Management, validations, qualifications, calibrations)
• Deep knowledge of quality standards ISO 13485 and FDA 21 CFR 820
• Familiar with Medical Device Regulations relative to CE mark (MDR 2017/745) and FDA medical device regulations
• Knowledge of validations Risk Assessment
• Familiar with active and software containing medical devices

Neuroelectrics is a creative, high-tech company offering the best in class non-invasive and high definition electrical brain stimulation technology for personalized neuromodulation. By measuring and modifying brain function, we aim to restore brain health, minimize disabilities and create a better life for patients.

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