Quality Engineering Device Manager
Location:
Cambridge , Massachusetts
Posted:
December 11, 2017
Reference:
1702458
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Quality Engineering Device Manager in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Engineering Device Manager working on the Research and Development Quality Assurance team, you will be empowered to help shape the strategy, and a typical day will include:

POSITION OBJECTIVES:

  • The Quality Engineer will liaise with technical groups in the development of drug delivery devices. Scope includes a wide range of devices, such as: needle protection systems, fluid transfer devices, pen injectors and automatic pen injectors.
  • The qualified candidate will work with technical teams to ensure successful device development of these devices. The Quality engineer will work closely with team members to develop compliant detailed engineering specifications, device design and development, support verification, validation and regulatory submissions of the combination devices.
  • The role of the Quality engineer is to work within a cross functional organization to provide Quality oversight, ensure compliance, utilize technologies and methodologies that support robust device development.


POSITION ACCOUNTABILITIES:
  • Work cross functionally with individuals and project teams in Marketing, Operations, Technical Development and other functions as necessary.
  • Support CMO site selection, product transfers, device commercialization, new technology evaluation and development product produced at CMO’s.
  • Assist in the creation and assessment of product requirements to determine technical coverage and proper integration of different subsystems.
  • Identify deliverables and establish documentation required for project support in accordance with applicable SOP’s, standard and design controls.
  • Review, execute and approve requirement documents, design documents, specifications, development plans, characterization plans, verification and validation plans (including human factor studies) and test protocols, reports and other related product development documents for assigned products.
  • Review and approve process validation reports from CMO’s to assure they meet regulatory requirements and support regulatory filings.
  • Provide oversight of design verification and validation performed by CMO’s and assure design or the device and packaging are verified.
  • Troubleshoot and direct the resolution of complex quality issues during design and development and during technical transfer.
  • Participate in the resolution of complaints.
  • Develop/maintain quality risk management plans; utilize risk management tools to identify and mitigate CMO quality and compliance risks, ensuring CMO sites are in a state of continuous inspection readiness.
  • Conduct FMEAs; assist in writing Risk Management Report.
  • Develop and maintain trace matrices during the development process.
  • Create and update any quality systems documents related to combination products development



Qualifications:


EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • This position requires at a minimum a bachelor’s degree, preferably in a technical field relating to engineering or science
  • 5-10 years’ experience with engineering processes and procedures in the medical device industry dealing with product development.
  • Product design/development (design controls) experience from concept to post launch for Europe & US submissions.
  • Experienced in protocol and report writing, process and test development, prototyping, design verification. DOE/SPC process optimization and validation (IQ, OQ, PQ) and risk management activities.
  • Good communication skills, team player and ability to multi-task.
  • Promotes process improvement
  • Proficient in Microsoft Office, Visio and electronic trace matrix software.
  • Knowledge of quality and statistical analysis is required.


LICENSES/CERTIFICATIONS:

  • CQE


TRAVEL REQUIREMENTS:

  • 15% Travel


WHAT TAKEDA CAN OFFER YOU:
  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com .

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.



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A little about us:
Takeda fosters an inclusive environment where all employees are empowered to shine.

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