Quality Assurance Specialist

hace 2 meses

Alajuela, Alajuela, Costa Rica Nevro A tiempo completo
Job Summary

The Quality Engineer is responsible for ensuring compliance in product and process development, validations, and process optimization for Class III medical devices. This is a hands-on role where the Quality Engineer will apply intensive knowledge of engineering and quality principles and practices for implantable medical devices and accessories.

Key Responsibilities
  • Establish and maintain receiving inspection procedures to support product and receiving inspections.
  • Write, review, and/or approve validation plans, protocols, and reports in accordance with applicable regulatory requirements and Nevro SOPs.
  • Analyze data and perform statistical analysis to ensure validation meets predefined acceptance criteria.
  • Collaborate with cross-functional teams to implement and align Quality Control inspection plans, requirements, and methodologies.
  • Provide guidance to manufacturing processes and personnel.
  • Work with cross-functional teams to implement comprehensive preventative maintenance work instructions and revalidation requirements.
  • Review and disposition Non-conformance reports and perform Root Cause analysis to determine corrective and preventive action activities.
  • Ensure appropriate process outputs and process controls are translated into Quality Control Plans, Work Instructions, and Device Records.
  • Evaluate risk, manage risk assessment activities, and create associated documentation.
  • Investigate and implement solutions to internal and external audit findings.
  • Lead Supplier management and Supplier Quality activities for local suppliers.
  • Collaborate with Suppliers to identify and define corrective actions and follow-up to ensure completeness and effectiveness of Supplier improvements to meet Nevro and applicable regulatory requirements.
  • Participate in audits (internal & external) and regulatory agency inspections.
  • Responsible for review/release of Batch Record(s) and review of other documentation from medical device manufacturing and packaging suppliers, ensuring all activities comply with quality requirements and Nevro procedures.
  • Responsible for performing Quality assessment of changes to manufacturing processes, materials, and procedures and ensuring applicable and appropriate documentation are generated.
  • Supervise Quality Inspectors and Technicians.
Requirements
  • Bachelor's degree in a relevant technical discipline required; advanced degree preferred.
  • Equivalent years of experience may be substituted for education requirement.
  • No fewer than four (4) years of directly related experience, with at least two (2) of those years in a Class II or III medical device environment, preferably in implantable devices.
  • Experience in the medical device industry and with extensive knowledge performing their function within the Food & Drug Administration (FDA), Quality System Regulations (QSRs), International Organization of Standardization (ISO), and Implantable Medical Device Directive.
  • 2+ years in Quality Assurance and/or Quality Systems function in the Medical Device industry.
  • Prior experience working with US companies a plus.
  • Knowledgeable with the ISO Requirements and QSR requirements.
  • Strong communication skills, both verbal and written, and the ability to effectively communicate throughout all levels of the organization.
  • Experience in managing quality system activities not limited to product audits, CAPA, and supplier corrective action request (SCAR).
  • Cross-functional collaboration with Quality, Regulatory, Engineering, Manufacturing/Production, Supply Chain, etc.
  • Strong working knowledge of quality system processes, validations, and audits (internal and external).
  • Strong problem-solving, organizational, analytical, and critical thinking skills.
  • Root cause analysis and implementation of corrective action for process-related concerns.
  • Knowledge on sterilization and biocompatibility is a plus.
  • Experience performing Quality inspection to ensure products and processes comply with the relevant requirements of the QMS.
  • Analyze failure, corrective, and preventive action to respond to internal/external customer complaints.
  • Ability to travel on a needed basis.
  • Ability to work closely with peers in Redwood City, CA.
  • Ability to multi-task, work under pressure, and meet deadlines required.
  • Ability to effectively present information and respond to questions from groups of managers, clients, and customers.
  • Ability to communicate fluently in Spanish, both verbal and written.
  • Ability to communicate fluently in English, both verbal and written.

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