Quality Engineer Shift B

hace 7 meses

Alajuela, Costa Rica Nevro A tiempo completo

Job Summary

& Responsibilities

The Quality Engineer is responsible to ensure compliance in product and process development, validations and process optimization, line support, acceptance sampling, and continuous improvement for Class III medical devices. This is a hands-on role where the Quality Engineer will apply intensive, self-directed and diversified knowledge of engineering and quality principles and practices for implantable medical devices and accessories. Will work independently with little to no supervision and exercise considerable discretion in determining objectives and approaches to significant organizational projects or assignments.

#LI-JS1

Role Requirements

Applying knowledge of QSR and GMP requirements on a daily basis, the duties and responsibilities for this position include, but are not limited to, the following:

Establish and Maintain Receiving Inspection procedures to support product and receiving inspections. Write, review and/or approve validation plans, protocols and reports (e.g., cleanroom, equipment) 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 in Costa Rica, and Redwood City, CA to implement and align Quality Control inspection plans, requirements, and methodologies. Provide guidance to manufacturing processes and personnel. Work with cross-functional team to implement comprehensive preventative maintenance work instruction as well as revalidation requirements. Work with production and inspection staff to analyze, evaluate, understand and resolve any assembly inconsistencies or product/production issues. Review and disposition Non-conformance reports. Perform Root Cause analysis in order 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, as appropriate 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, and ensure that all activities comply with quality requirements and Nevro procedures. Responsible for performing Quality assessment of changes to manufacturing processes, materials, and procedures and ensure applicable and appropriate documentation are generated. Supervise Quality Inspectors and Technicians. Perform other duties as required.

Skills and Knowledge

Role Requirements

Bachelor’s degree in relevant technical discipline required; advanced degree preferred. Equivalent years of experience may be substituted for education requirement

Skills and Knowledge

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 device; 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 13485) 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 biocomptability 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 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 the 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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