PRINCIPAL CSV & PROCESS VALIDATION ENGINEER-00000T7V
Description
Acclarent, Inc., a member of the J&J Family of Companies is actively recruiting for a Principal Quality Engineer to be located in Menlo Park, CA.
Acclarent, Inc. is a medical device company in Menlo Park, CA that was established in June of 2004. The company is dedicated to the development of innovative devices providing new technologies to further meet the needs of ENT patients. Acclarent's initial focus is on achieving the goals of sinus surgery with novel, endoscopic, catheter-based tools - Balloon Sinuplasty™ devices. Through the Balloon Sinuplasty™ technology and our Relieva® product portfolio we offer ENT patients another option to conventional endoscopic surgical technologies. FDA clearances for these devices were completed in 2005 and the products were commercially launched in the US that same year. Through our core technologies and commitment to innovation, Acclarent will continue to advance novel devices in all areas of ENT. The Senior Clinical Research Associate (CRA) will support pre- and post-market otology clinical studies worldwide.
The Principal Validation Engineer provides quality oversight of validation, including Computer System Validation (CSV), equipment and process validation.
The duties and responsibilities of this role include, but are not limited to:
Providing leadership on software projects/initiatives pertaining to manufacturing, laboratory and GxP/QSR-impacted business and computer systems; guiding/mentoring project team members regarding the development and life cycle management of software, equipment, and process validation deliverables; and developing requirements, writes protocols and reports for software validation.
Leading/assisting in the development, coordination and implementation of software quality compliance programs and activities (i.e., policies, procedures and projects) throughout Acclarent to ensure that all QSR-GxP systems that are impacted by the Quality System are developed, validated and maintained in adherence to regulatory (i.e., FDA, ISO) and Acclarent/J&J standards.
Supporting regulatory audits in the area of software/equipment/process validation, as required; creating/reviewing documents that are generated as part of the software development life cycle, including the creation and/or review of documents, such as system user requirements, compliance plans as they may relate to a GxP system, validation protocols and reports as well as user test scripts; and is responsible for driving improvements and efficiencies on the validation process.
Creating CSV training materials and conducts CSV training, as needed; leading CAPAs that are related to software/equipment/process validation; performing failure investigation as it pertains to software/equipment/process validation; performing other validation and quality assurance-related duties, as required.
Qualifications
A minimum of a Bachelor’s degree in a technical discipline is required, with a minimum of 8 years of professional experience in systems development/validation is required, with at least 3 years in FDA-regulated life science environments. An advanced Degree in Computer Science or in Electrical Engineering is preferred.
Demonstrated working knowledge of FDA 21 CFR 820, the Quality System Regulation, ISO 13485, and the EU Medical Device Directive is required. This candidate also must possess the ability to work quickly within electronic/software-based systems and to effectively collaborate with system developers on validation plans and protocols, as well as posses a demonstrated experience in defining test strategy, designing and developing test cases from software requirements and architecture designs.
Technical ability to understand the mechanical, electrical and software of the systems is required. Strong written and oral communication skills are required. Excellent problem-solving and troubleshooting skills and the ability to work independently are also required. Excellent organizational skills and attention to detail is required.
An ASQ certifications in Software Quality Engineering (CSQE) and Quality Auditing (CQA) or equivalents are preferred. Demonstrated working knowledge of IEC 62304 is preferred. Experience leading other verification/validation engineers or contractors is preferred. Experience defining and collecting software quality metrics is also preferred.
This position is located in Menlo Park and requires up to 15% travel.
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J2W:LI NA
Primary Location:North America-United States-California-Menlo Park
Organization: Acclarent, Inc. (6206)
Job Function: Quality (Eng)
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