Quality Systems Manager – Corporate Quality Assurance

Quality Systems Manager – Corporate Quality Assurance

Quality Development
Foster City, CA
Posted 3 years ago

Engineering Program Manager – Job Overview:

The key responsibilities of this position include improvement & development functions for “The Cardiac Check” system. Key role also encompasses new product development, product enhancements, maintenance of operational systems and sustainable engineering. As an engineering program manager, you will also adopt a “minimum acceptable quality” approach for all the aspects in execution of key responsibilities for this position.

The right candidate will use both: vigilance & alertness in regards with potential compliance related problems and should report such findings / observations to the “Head of Quality”. Further, the “Engineering Program Manager” will also be responsible for compliance and he/she needs to ensure that all regulatory requirements in regards with design control as indicated in the “Quality System Documentation” are met. He/She will be reporting directly to the “Vice-President of Technology & Development” and will be directly responsible for overall co-ordination, direction, execution, implementation, completion and control of specific medical device projects. The “Engineering Program Manager” will need to ensure that the project(s) are carried out in compliance with company strategy, goals and time-frame commitments.

Engineering Program Manager – Duties & Responsibilities:

  • The right candidate will lead the implementation and planning of major medical device projects.
    He/She will help facilitate in the definition of the project’s scope, deliverables and goals.
  • One of the important responsibilities will include: defining the project tasks and the requirement of resources for it.
  • The right candidate will also be proficient and have experience in project plan development.
  • Key duties of the “Engineering Program Manager” will include assembling & co-ordination of project staff.
  • He/She will also be involved in finalizing the project budget, managing project resource allocation and planning for project completion timelines and schedules.
  • Key responsibilities also include: using appropriate tools to track project deliverables; providing direction & support to the project team; ensuring quality compliance at all levels; monitoring and reporting on the developments/progress of the project to all the stakeholders.
  • From time to time, he/she will need to ensure that the product performance confirms to product guidelines by way of conducting tests at various stages of product development.
  • Key duties also include: project status report preparation; controlling costs by approving expenditures & administering contractor contracts for external contractors; maintain company reputation by ensuring the federal and state regulations are complied with at all times; contribute to the team effort by providing support and direction as and when needed.

Engineering Program Manager – Qualifications:

To perform the job successfully, the right candidate must be able to perform every essential duty satisfactorily & meet competency & experience requirements detailed below:

Program Manager – Core Competencies:

  • Apart from excellent communication skills, the “Engineering program manager” should be skilled in: Requirement Analysis, Problem Solving, Decision Making, Planning and organizing.
  • He/She should possess the ability to lead both internal teams and external partners, be an effective negotiator, and should be able to perform in varying market conditions and under stress.

Engineering Program Manager – Education & Experience:

  • BS degree + in scientific (chemistry, biochemistry) or engineering discipline.
  • qualification in project management or equivalent (PMP, MPM).
  • A minimum of five years experience in medical device or medical diagnostic industries.
  • knowledge of both: practical and, theoretical aspects of project management.
  • knowledge of latest project management techniques, tools and software.
  • Minimum two years work experience in project management capacity, managing both external and internal complex projects.
  • Previous experience in people management & cross-functional teams proven expertise in strategic planning.
  • Previous exposure to risk management.
  • Proven experience in change management.
  • Up-to-date working and applied Knowledge of FDA design control and ISO 13485 product realization requirements for medical devices.
  • Previous knowledge of software design and systems engineering is a plus.
  • Complete knowledge of product life-cycle and various strategies that can be applied at different stages.
  • Experience in new product development from early conception through production launch.

Job Features

Job CategoryMedical Device, Pharmaceutical

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