Posted to MedZilla on 12/9/2019

Takeda Pharmaceuticals

US-MA, Senior QA Specialist SR0037036-MZ


Primary Role

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

  • BS and/or MS in engineering or equivalent technical discipline required, and advanced degree preferred
  • 6+ years of device and/or combination product quality engineering experience within a medical device or biopharmaceutical organization required
    Good understanding of E.U., U.S. and international medical device regulations and standards including FDA 21 CFR Part 820, 803, ISO 13485, ISO 14971, E.U. Medical Device Directive (MDD) and relevant CFRs required
  • Experience with deviations, non-conformances, out of specification investigations and CAPA - required
  • Experience with SAP, Trackwise or similar systems required
  • Prior experience in a product release role Required
  • Experience in providing quality support to on-market/commercialized products required
  • Experience in working with external suppliers &/or contract manufacturers required
  • Experience in leading quality projects/activities required, and specific experience in leading remediation projects preferred
  • Experience with risk management processes and tools required
  • Experience with statistical and six sigma methods required, and Green/Black Belt preferred
  • Experience with drug delivery injection systems preferred

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

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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Pay Transparency Policy -

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, 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.

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