Posted to MedZilla on 11/12/2019


Takeda Pharmaceuticals

US-MA, Device Product Quality Surveillance Lead SR0040382-MZ


 
 

OBJECTIVES/PURPOSE

Device Quality Product Surveillance Lead is an experienced Quality and Technical professional who supports the overall device and combination product quality strategy to maximize the benefit and sustainability of Takeda s in-line products and to bring Takeda s pipeline products to a sustainable existence on the market.

  • Drives improvements for Device and Combination Products(DCP) and ensures robust post market and clinical product review. Oversight on clinical and commercial DCP complaintstrending

    • Customer Focus
    • Product and process Surveillance
  • Participates ongoing Quality initiatives, Integration support andOperational Excellence.
  • Assesses product quality performance to demonstrate levels of control,capability and compliance. Responsible for assessment of trending for all keyKPIs.

  • Visual Management for Device QualityOrganization.

  • Internal and external audit support including site readiness.

  • Responsible for global product surveillance data, product risks and performance capability. Manage Takeda Device and Combination Products post market surveillance, clinical reviews, and interaction with APQR/PQR group to ensure combination products and sterile water for injection data is captured.

ACCOUNTABILITIES:

  • Drives device improvement and quality assurance and compliance to ensure robust development, manufacturing, testing, and productreview.
  • Provides input to incidents investigations, complaints, non-conformances, CAPAs and changecontrols
  • Surveillance and monitoring device and combination products lifecyclemanagement
  • Assessment of customer complaints, trending of complaints, accountable for device CAPA support, MDR/Vigilance reporting and updating all risk-related reports if requiredof specific medical devices, in addition to Incident escalation execution for Device and Combination products asnecessary.
  • Influences QMS strategy to enhance and execute sustainable Device Quality supportfor internal and external manufacturing, packaging, testing and release of device and combinationproducts.
  • Management of Post Market Surveillance process and schedule for Takeda DCPportfolio.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Bachelor s Degree in BS in Engineering or equivalent technical discipline required. Advanced degreepreferred.
  • At least 3 5 years of experience working with medical devices and/or combination products in a regulated healthcare industry, with a minimum of 1-3 years Quality Assurance and/or Product Quality Surveillanceroles.
  • Good understanding of EU, BREXIT, US and international medical device and combination products regulations and standards including but not limited to Part 4, CFR 820, 803, ISO 13485, MDSAP, ISO 14971, E.U. Medical Device and In-Vitro Diagnostic Directive (MDD &IVDD).
  • Familiarity with Medical Device Regulations (MDR) and In-Vitro Diagnostics(IVDR) Regulations.
  • Experience with Class I & II & III sterile and non-sterile medicaldevices.
  • Experience working with combination products.
  • Experience interacting and collaborating with cross-functional globalteams.
  • Project/program management and operational excellencepreferred.

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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.


Please visit our website at takedajobs.com

 
 


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