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Sr. Software Quality Engineer - Fairfield, NJ in Fairfield, NJ at Getinge

Date Posted: 11/27/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Fairfield, NJ
  • Experience:
    Not Specified
  • Date Posted:
    11/27/2018

Job Description

Job Functions: (Primary “essential” duties and responsibilities)

  • Plays key role in providing full guidance and direction on acceptability of Software Quality deliverables, based on requirements and templates given and following the correct corporate policy requirements. This is not inclusive of Medical Device Research and Development and Production Software.
  • Acts as an effective team member who provides independent review on deliverables used to develop, implement and maintain manufacturing and Quality Software.
  • Communicates the value of the Software Quality process at Maquet and champions departmental or cross-functional software Quality Assurance initiatives.
  • Ensures buy-in from project team members to the disciplines, decisions and practices of the Software Quality organization.
  • Proactive involvement in continuous improvement activities for the software Quality life cycle while ensuring that Maquets’ software systems are defensible for regulatory requirements.
  • Develops, modifies, applies and maintains standards for Software Quality methods, processes and procedures which meet Maquet and external regulatory requirements and implements against them.
  • Establishes methods for monitoring the compliance of software system processes, standards and procedures.
  • Provides expertise on software validation requirements to project teams that are implementing software systems and provides independent review to teams.
  • Teaches and coaches less experienced colleagues and executes on projects along with other members of the Software Quality team.
  • Functional engineering role includes manufacturing and Quality Software and computerized system validation and maintenance.
  • Other Duties as assigned.

Required Knowledge, Skills and Abilities:   

  • Must demonstrate the ability to problem solve.
  • Must possess good communication skills and be able to communicate to all levels of organization.
  • Must have organizational skills and attention to detail.
  • Proofreading skills are required.
  • Must have ability to identify technical user issues and troubleshoot basic systems issues.
  • Must demonstrate ability to work independently and manage multiple tasks and priorities.
  • Must demonstrate sound judgment and strong decision making skills.
  • Must show initiative and ability to work cross functionally to resolve issues.
  • Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
  • Establish and support a work environment of continuous improvement that supports Fairfield and Mahwah sites Quality Policy, Quality System and the appropriate regulations for the area of support

Minimum Requirements: 

  • A Bachelor’s Degree in Software Sciences or other related field is required.  A Master’s Degree is preferred.
  • A minimum of 6 to 10 years’ experience in software system validation or equivalent within software sciences is required
  • Experience with project management is required.
  • Must be able to clearly define the methods for complying with regulations that apply to Quality Systems and Manufacturing Systems software.
  • Must be able to provide direction to software/computer system development teams on the requirements for complying to corporate policies.
  • Must be able to design, implement and present training that effectively educates individuals on good software engineering practices and compliance requirements.
  • Must demonstrate good interpersonal skills needed to manage and resolve issues from different business cultures.
  • Fundamental understanding of software/computer systems life cycle activities.
  • Fundamental understanding of software/system configuration management and change control is required.
  • Fundamental understanding of FDA, ISO and other applicable requirements.

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Getinge Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.