Sr Associate, Quality Assurance - United States
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|External Posting Title||Sr Associate, Quality Assurance|
|Job Description||The Sr. Associate will be responsible for the following;|
• Lead and manage review and approval of SDLC deliverables in accordance with Software as Medical Device and Design Controls procedures.
• Review and approve plans, protocols and reports generated as part of the software development process. Determine and enforce quality and safety requirements in accordance with company needs and ensure compliance to design control procedures.
• Represent Device Quality and Compliance on cross-functional teams in support of SDLC activities
• Act as subject matter expert in developing and revising validation documents ensuring compliance with regulatory requirements
• Lead and facilitate Risk Assessment (Desgin (system) FMEA) and Mitigation. Review and approve risk management documents
• Provide quality input in supplier assessment and selection. Perform periodic evaluation of supplier performance. Participate in supplier audit as part of supplier oversight.
• Provide guidance, training, and support to device development team in their validation efforts, to ensure compliance.
• Review and approval for quality issues (e.g. deviation) and technical matters (e.g. design changes, verification and validation) with impact to design control and risk management
• Lead efforts to implement and maintain Quality processes / SOPs for devices in the respective device development
• Participate and support regulatory inspections related to Software as Medical Device QMS
• Advise technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed
|Location||Cambridge, MA, US|
|Job Category||Information Technology, Manufacturing, Operations, Technology & Innovation (PO&T)|
|Qualifications||8 + years experience, preferably in medical device and/or pharmaceutical industries|
Knowledge of IEC 62304, Medical Device Software - Software Life Cycle processes
Knowledge of FDA Quality System requirements, ISO 13485:2003 (Quality System) requirements
|Education||Bachelor’s degree required, preferably in Life Sciences or Software Engineering|
Master's degree preferred
|About Biogen||Corporate Overview|
Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. As a company, we are focused on improving science education and limiting the impact of our company on the environment. In 2015, we became a carbon neutral company and ranked first place on Newsweek’s 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science’s list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.
Nearest Major Market: Cambridge
Nearest Secondary Market: Boston
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