The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for an Staff Product Software Quality Compliance Engineer aligned to Biosense Webster located in Irwindale, CA.
The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing.
Biosense Webster is the global leader in the science of diagnosing and treating heart rhythm disorders and one of the fastest-growing businesses within Johnson & Johnson. Learn more about Biosense Webster at www.biosensewebster.com
· The Staff, Software Quality Compliance Engineer will provide software quality compliance principal expertise, both external (Regulations) and internal (J&J, MD&D and BWI standards and procedures) as well as provide training to software development teams, staff, contractors and business partners on BWI software quality compliance procedures.
· The Staff, Software Quality Compliance Engineer will lead compliance and risk management activities for software projects or software portion of systems projects, and continually improve software quality compliance processes.
· Improve technical expertise and understanding of regulatory requirements. The position also will assure that robust, reliable and compliant systems are transferred to users, and will assure that project software change control is compliant with procedures.
· Implement and manage the BWI Computer System Inventory and systems landscape in a compliant manner.
· Implement and manage the processes for computer systems that ensure the systems are maintained in a validated state throughout their lifecycle.
· Implement Change Management and Periodic review procedures for BWI systems.
· Additionally, this role will implement systems to address changing regulations; represents SQC functions during regulatory inspections; recommends issue resolution to senior management for significant capability and compliance issues, and will resolve and seeks consensus across affected business areas.
· The individual will ensure that all applicable Quality System Regulation, including FDA and ISO (i.e. QSR 21, CFR 820, Part 11, ISO13485, ISO 62304, ISO 14971, GaMP 5 but not limited) and applicable statutory/regulatory (e.g. FDA and ISO) compliance are considered and emphasized in all computer Systems Validation plans and actions.
· Will ensure that documented evidence exists to provide a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical to quality attributes.
· She/ he will establish and recommend changes to standard operating procedures in all areas related to Computer Systems Validation and be responsible for providing Quality System Regulatory interpretation, consulting, training, and assessment to ensure project teams are aligned with current regulatory requirements, standards, and current industry trends (FDA QSR 21 CFR 820, Part 11, GaMP 5 / ISO13485, ISO14971 / ISO 62304 quality system requirements).
· The individual will ensure and/or develop appropriate methodologies, policies and procedures to deliver business solutions consistent with the company and department Vision and Mission, will lead continuous improvement of the Software Development Lifecycle Management process and clarify business needs and turn them into solution designs and will serve as the technical subject matter and expert and communicates to auditors and investigators on Computer Systems Validation process, and will serve as the technical expert for the organization in the application of Software Development Lifecycle Management advanced theories, concepts, principles, and processes for an assigned area of responsibility (i.e., subject matter, function, type of facility, or equipment, or product).
· The Staff, Software Quality Compliance Engineer will drive strategic initiatives, programs or projects, including formulating long and short term systems development goals and will anticipate and resolve issues/barriers that impede progress.
· The individual will lead, influence and negotiate to achieve business strategies and deliver results for internal/external partner(s) consistent with the company and department Vision and Mission.
Strong knowledge of Product Software Lifecycle Development process is required.
The candidate must have excellent both written and verbal communication skill and capable of working independently and in a team setting.
· A minimum of a B. S. Bachelor’s degree in engineering and/or scientific discipline or equivalent. A minimum of 8+ years’ experience in Quality and/or Software Quality Assurance in the Medical Device or Pharmaceutical industry required, or a Master’s degree in engineering and/or scientific discipline with 6 or more years of related experience is required.
· Strong Computer Systems Validation (Software development Lifecycle management) skills required. Leadership ability in developing achievable high-quality computer Systems Validation in partnership with various departments, such as, R&D, Operation, Manufacture, Service etc., and managing the implementation and execution of these SDLC goals is strongly preferred.
The ability to effectively
manage external development partners, consultants and contactors desired.
· A working knowledge of Microsoft office products (MS Word, Excel) and other Testing Software tools is required.
· Strong working knowledge of FDA QSR 21 CFR 820, Part 11, GaMP 5 / ISO13485, ISO14971, ISO 62304 quality system requirements and the ability to provide an expert knowledge of both regulatory requirements and other compliance areas to minimize risk across franchise required.
Engineering experience with exposure of product design verification, as well as
product and process validation activities highly required.
· The ability to work and communicate in a cross-cultural environment is required.
· Strong Project Management and leadership skills are required.
· Demonstrated competence in change management preferred.
· Project management methodologies preferred.
· CSV/Software quality compliance.
· Change management, periodic review.
· This position is located in Irwindale CA, and may require regular travel to Irvine, CA.