Responsible for contributing, supporting and maintaining the Quality System within the requirements of FDA’s Quality System Regulations (QSR) and ISO 13485 (ISO).
This position is also responsible for providing QA support, where needed, but not limited to Document Control, QA Operations and Quality Systems.
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 :
Responsible for establishing and maintaining Document Control system.
Release and maintain QMS documents including the processing of new document and document revision requests.
Ensure the consistency and quality of documents by editing and proofreading documents prior to release.
Notify cross functional departments and Purchasing on part dispositions and on the effective changes related to the process / design.
Schedule periodic document reviews to ensure documents are compliant with Nevro requirements and processes as well as external regulations.
Responsible for ensuring departmental SOP & WI reviews are performed per internal requirements.
Maintain and archive documents in an organized and retrievable state (manual or electronic) for compliance to procedures, regulations and standards as well as accountability and access by a regulatory body.
Responsible for managing Quality training files for personnel. Ensure that the appropriate training is added according to the role and provide follow up to facilitate on time training.
Responsible for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
Interface with cross functional team to ensure internal and external compliance requirements are followed and implemented per requirements.
Responsible for the maintenance to be in compliance with applicable regulatory standards and keeps up to date on current regulations and industry standards.
Manage CAPA program by developing and implementing the strategy, systems and tools to ensure a robust corrective and preventive actions (CAPA), tracking of CAPA completion, and assessment of effectiveness.
Participates in internal and external regulatory site visits, inspections, and audits. Including ensures that pre and post-inspection activities are completed including scheduling, record review, training, logistics, etc.
Responsible for managing the backroom during internal and external audits. Ensure that the documents released in QMS are presentable during the audit.
Support with External Audits activities when required and as directed. Performs follow up to ensure audit action items are closed.
Apply proactive, systematic problem-soling methodologies in identifying, prioritizing, communication and resolving quality system issues.
Responsible to ensure timely release of products by reviewing and approving Lot History Records (LHRs) per internal requirements.
Manage the coordination of Quality (monthly and quarterly) metrics, analyze trends, drive continuous process improvements and generate reports related to the Quality System performance.
Perform other duties as assigned.
Bachelor’s degree in relevant technical discipline required; advanced degree preferred
Equivalent work experience may be substituted for education requirement
Skills and Knowledge
No fewer than Five (5) 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);
Experience with 21 CFR Part 11 and Computer / Quality System Software management methods preferred;
5+ 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 FDA Submission process, ISO Requirements and QSR requirements;
Strong communication skills, both verbal and written, and the ability to effectively communicate throughout all levels of the organization;
Strong technical capability, effective interpersonal skills and be able to work independently;
Knowledge of documentation systems, specifically product qualification (protocols, reports, software, validation data), quality system (procedures, forms, quality records), and manufacturing (Bill of Material, routers, procedures, Device History Records, Device Master Records) documentation, among others;
Experience with electronic documentation systems such as Arena, EtQ, preferred;
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;
Ability to multi-task, work under pressure and meet deadlines required.
Must be organized, detail-oriented and adaptable
Proficiency in Microsoft Office, Access, Excel, Project, as well as exposure to technical document source applications such as Adobe Acrobat, SolidWorks, and Illustrator is recommended.
Ability to communicate well with all levels of staff and present data to Management when needed.
Ability to communicate fluently in Spanish, both verbal and written.
Ability to communicate fluently in English, both verbal and written.