US-MA, Senior QA Specialist SR0037036-MZ
Primary responsibility for all medical device product release activities to ensure that products are manufactured and released in accordance with regulatory requirements and the principles and guidelines of current Good Manufacturing Practices and Good Documentation Practices. The Quality Engineer (QE) will provide technical quality leadership and support for Takeda s on-market medical device and combination products. Work collaboratively with internal Quality and cross-functional colleagues to ensure Takeda s medical devices and combination products comply with FDA 21 CFR requirements and international standards (e.g., FDA, ISO, AAMI, ANSI).
50%: In process and final release of medical device products from contract manufacturing organizations (CMOs) for E.U. and international markets including manufacturing, inspection, packaging and labeling batch records to ensure compliance. Generation of associated product release certificates, archiving of electronic and hard copy batch documentation.
Responsible for ensuring all appropriate CMO batch related documents are available, and all documentation issues including queries, deviations, change controls, out of specification investigations and CAPAs are closed to enable release of products in a timely manner. Communication with cross functional team and CMOs to align on product release timelines and resolve batch record issues. Actively participate in project meetings as required.
Subject matter expert for medical device product release processes.
15%: Responsible for oversight activities relating to contract manufacturers including creation and updating of quality agreements, processing new supplier requests and supplier change notifications. Supplier quality related activities during transition of responsibilities from SQM to Device Quality.
10%: Support medical device complaint investigations including batch record reviews
10%: Support setup of medical device release processes for new product launches, including managing associated change control actions
5%: Develop, maintain and report quality system metrics relating to medical device product release activities as required.
5%: Ensure that the documentation systems to support Device Quality are maintained.
Prepare and/or update standard operating procedures, device master records and product specifications. Review master batch records from contract manufacturers as required.
5%: Lead Device Quality continuous improvement projects
Education & Experience Requirements
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Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, 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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