Assure compliance with software procedures, identify task dependencies, guide teams on appropriateness of the development life cycle, and assure development and maintenance efforts are effective and compliant.
Provide software quality engineering principal expertise, both external (Regulations) and internal (MD&D and ASP standards and procedures), including leading both internal and external audits for software quality systems.
Provide training to software development teams, staff, contractors and business partners on ASP software quality engineering procedures.
Leverages software experience and technical knowledge to lead compliance and risk management activities for software projects or software portion of systems projects.
Continually improve software quality engineering processes based on industry trends and best practices. Improve software technical expertise and understanding of regulatory requirements.
Assure that robust, reliable and compliant systems are transferred to users with a prioritization on patient safety.
Assure that project software change control is compliant with all quality procedures and work instructions.
Implements systems to address changing regulations.
Represents SWQE function during regulatory inspections.
Recommends issue resolution to senior management for significant capability and compliance issues.
Resolves 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, ISO13485, IEC 02304, ISO 14971.), security, records retention, Sarbanes-Oxley laws 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.
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 / ISO13485 quality system requirements).
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.
Will serve as the technical expert for the organization (worldwide) 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).
Responsible for communicating business related issues or opportunities to next management level.
Performs other duties assigned as needed.

Our Needs

Bachelor s degree (or equivalent) in Engineering (software, computer, computer science or electrical) AND 5 or more years of relevant experience OR Graduate degree AND 3 or more years of relevant experience.
ASQ CQE, CQM, CQA; Process Excellence yellow, green or black belt optional.
Experience working in a regulated environment (Medical Device, Aerospace, etc.). This includes knowledge of, and experience with, applicable standards, GxP requirements and applicable regulations.
Development experience with any or all: imbedded product software, ATE, customer/product data management, product connectivity.
Strong knowledge of system development methodologies and software program metrics
Experience with system/software Quality Engineering methods, techniques and principles.
Thorough understanding of GxP standards and medical device regulatory and compliance environment including: ISO 13485, 21 CFR Part 820 and 21 CFR Part 11.
Thorough knowledge of and in-depth experience with system development configuration management and change control processes, testing (V&V), issue tracking and defect management.
Experience with cyber security and data integrity requirements, methods and implementation
Experience managing projects, and demonstrating project leadership abilities.
Experience with a proven track record of implementing appropriate risk mitigation w/in-depth knowledge of ISO 14971 Risk Management and IEC 62366 Software Development Processes
Experience with GxP data collection.
Demonstrated ability to perform hands on troubleshooting and problem solving.
Working knowledge of failure investigation processes, computer code static analysis methods and tools.
Clear and effective communicator (presentation, technical writing, verbal)
Strong understanding of either embedded software systems or cloud applications (SaaS).
Leadership ability in developing achievable high-quality computer Systems Validation in partnership with various departments, such as R&D, Operations, Service etc. and managing the implementation and execution of these SDLC goals is strongly preferred.
Ability to effectively manage external development partners, consultants and contractors desired.
Strong knowledge of Product Software Lifecycle Development process required.
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 / ISO13485 quality system requirements and the ability to provide an expert knowledge of both regulatory requirements and other complianc3e areas to minimize risk across franchise required.
Extensive Quality Engineering experience with working knowledge of product design verification, as well as product and project validation activities required.
Excellent both written and verbal communication skills and capable of working independently and in a team setting.
Strong Project Management and leadership skills required.
Demonstrated competence in change management preferred.
Project management methodologies required.

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