Posted to MedZilla on 11/12/2019


Takeda Pharmaceuticals

US-MA, Manager, Device Quality Assurance SR0039935-MZ


 
 

Primary Role

Device Quality Assurance Manager will:

  • Execute activities for the Quality function supporting software applications classified as medical devices and ensure quality and regulatory standards are met.
  • Provide Quality support and oversight.
  • Handle multiple projects.
  • Demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership.
  • Have a functional understanding of FDA (21 CFR Parts 504, 803, 807, 820, 11, FDA Design Control Guidance, FDA General Principals of Software Validation), ISO (ISO 14971 and ISO 13485), MDSAP, MDR, ISO 62304, and global quality systems.
  • Have the ability to work productively in a cross-functional team model. Support DQA and DQEs.

Responsibilities

Lead ongoing daily departmental activities for areas of direct responsibility and when required assist other Quality areas in the successful performance of these activities.

  • Manage
    • The PST (Product Support Team) in regard to Complaint Handling, CAPA, and Incident Escalation
    • The CCB (Change Control Board) for ongoing product changes.
    • Management Review
  • Coordinate Commercial Software Applications Device training.
  • Write, review, analyze and revise
    • Written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate and Regulatory Requirements.
    • Product complaints, change controls, and CAPAs.
  • 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.
  • Be directly involved in and where appropriate lead multiple process/product improvement projects which may include any of the following - Kaizen, or other focus groups, quality system process improvements, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
  • Support audit readiness efforts for assigned areas and assist other areas within the entity in understanding FDA, ISO and quality requirements. Maintain a high level of expertise in current regulatory requirements and serve as a resource for compliance to these requirements.
  • Must be a recognized as an expert in their area by all levels of the facility and be able to demonstrate leadership ability.
  • Manage activities of self and possibly direct reports in achieving defined quality goals in an efficient, accurate and timely manner.
  • Other duties, tasks or projects as assigned.

Education & Experience Requirements

Essential:

  • Bachelor's degree in science or engineering
  • Software medical device or computerized systems experience is ideal.
  • Knowledge of Global Quality System requirements for Medical Devices specifically 21 CFR Part 820.30, ISO 13485, MDSAP, MDR, and ISO 14971. ISO 62304 is desired.
  • Minimum of 7 years of experience in Quality in the medical device industry is required.
  • Experience supporting FDA and other regulatory /notified body inspections is a preferred.

Desired:

  • Advanced degree in the life sciences, physical sciences or engineering
  • Experience in project management to drive improvements to the processes and products and lead cross-functional projects and.
  • Experience implementing and/or improving global software medical device Quality Systems.

Other Requirements

Domestic and international travel up to 5-10% for business meetings, corporate peers/collaborators, Device Supplier Audits, Contract Manufacturing Operators and to stay current with professional development opportunities.

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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