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Shire Device Quality Engineer - Software Medical Devices in Lexington, Massachusetts
Device Quality Engineer for software devices to help coordinate resources and activities for the Quality function supporting commercial software applications classified as medical devices including, but not limited to, supporting all phases of in-house and/or outsourced design and development as well as product support processes.
Represent Quality function as designee on the cross-functional Global Development Team (GDT), Hematology, as well as other franchises where strategy includes development of commercial software devices supporting the Shire pharmaceutical portfolio.
Manage quality activities as the manufacturer of in-house and outsourced developed software application medical devices (software devices) by ensuring, through allocation of resources, quality and regulatory standards are met for the following responsibilities:
Provide Quality support for the change control process for software devices.
Provide Quality support for the Design History File (DHF) for 510k and other regulatory submissions relating to software devices.
Provide Quality support for the design and development process, including risk management according to ISO 14971 requirements, for software devices.
Provide training relating to software devices is defined for the design and development and product support teams.
Ensure suppliers for software devices are appropriately qualified and documented per procedures.
Provide Quality support for the documentation process relating to software devices.
Provide Quality support for the complaint/CAPA/MDR/FCA processes relating to software devices.
Provide Quality support for ISO 13485 certification, Regulatory Audits, and Regulatory filings for software application devices and/or combination products.
Own and maintain design history files, including risk management files, for software application medical devices.
Support submission and approval of software devices in production including complaints, field corrective actions and medical device reporting.
Identify ways to improve efficiency and effectiveness of processes as part of the Quality Management System (QMS) for software devices meeting changing business needs and regulatory/quality requirements.
Support medical device reporting and post-market surveillance processes by working with compliance teams to have timely report filing and follow-ups.
Support Regulatory Affairs in creating/identifying technical information for 510(k) and other regulatory submissions.
Provide leadership for DQ individuals including mentoring, training, and potential supervision.
Support medical device and combination product Quality System initiatives. Develop strategies, priorities, and plans as required. Drive execution to plans, lead stakeholder meetings/ communications, and complete status reports. Work with external consultancy as required. Manage contract resources as required. Manage associated budget as required. Manage associated CAPA as required. Support related QS initiatives, such as inspection readiness, ISO 13485 certification, and integration projects. Build strong working relationships with Device Quality partners and other business process owners including cross-functional colleagues located both in the US and internationally.
Partner with product development and design quality teams on development activities, including risk management, quality planning, design input, design output and design transfer.
Education & Experience Requirements
Essential: Bachelor degree in a computer science/engineering or a related field, preferably pertaining to software development. 10+ years of medical device development and/or support experience. Extensive knowledge of Global Quality System requirements for medical devices. Extensive knowledge of both US and International Design Control and Risk Management requirements (specifically 21 CFR Part 820.30, ISO 13485, ISO 14971, ISO 62304, and software validation standards), as well as other applicable standards required. Experience in leading quality initiatives, managing cross-functional projects, influencing senior management, and driving organizational change required. Experience implementing and/or improving global medical device Quality Systems required. Experience supporting FDA and other regulatory /notified body inspections required.
Desired: Advanced Degree; Experience working in a post-market quality support function preferred. Knowledge of global requirements for Software Applications, mobile Medical Devices, and/or stand-alone Medical Devices.
Domestic and international travel up to 5-10% for business meetings with local staff, corporate peers/collaborators, Device Supplier Audits, Contract Manufacturing Operators and to stay current with professional development opportunities.
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Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.