Project Manager, Quality Assurance/Regulatory Affairs in Allendale, NJ at Stryker Corporation

Date Posted: 10/12/2018

Job Snapshot

Job Description

The Project Manager, Quality Assurance/Regulatory Affairs, shall play a pivotal role in the organization by leading and directing projects of moderate complexity, driven both by internal improvement initiatives and externally driven compliance requirements in the areas of quality and regulatory affairs. In partnering with business process owners, this role shall be responsible for all project management aspects of assigned projects from initiation to completion, including interfacing with all affected stakeholders and considerable, cross-functional resources.  More specifically, this role shall:


  • Be responsible for assembling project teams, assigning individual responsibilities and identifying appropriate resources needs, as well as identifying and recording all detailed customer requirements, constraints and assumptions.
  • Be responsible for development, maintenance and communication of project management deliverables, such as project charters, plans, schedules, status reports, close-out reports, etc., utilizing standardized project management methodologies and tools, to ensure successful and timely completion of projects. 
  • Be responsible for project budget estimation, monitoring and attainment throughout the project lifecycle.
  • Manage changes to project scope, schedule and costs using verification techniques in order to keep the project plan accurate, updated and reflective of the path forward.  This includes identification, assessment, monitoring and closure of project risks throughout the project lifecycle. 
  • Measure project performance to monitor the progress of the project, identify and quantify variances, perform any required corrective actions and report out / communicate to the necessary parties. 
  • Be eesponsible for improving project performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensuring project efficiency and boosting team morale.
  • Provide opportunities to develop best practices for project implementation and benchmarking opportunities for the larger cross-functional team and peer project managers. 

Qualifications

  • 4-year degree; Project Management Professional (PMP) certification or equivalent desired.
  • 5+ years of demonstrated project management experience; management of projects associated with quality / quality system and regulatory affairs initiatives in a regulated medical device environment is preferred.
  • Ability to generate and explain detailed project management deliverables utilizing standardized project management methodologies, tools and systems. 
  • Excellent interpersonal communication, collaborative teamwork and negotiation skills. Must be able to build trusting relationships and have demonstrated experience in working with and presenting to all levels within an organization.
  • Demonstrated knowledge of quality systems and regulatory requirements, such as ISO 13485, EU Medical Device Regulation, etc., for medical devices is preferred

Work From Home: No

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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