Poduct Quality Services Engineer

Job Description

 

Description

The SHS IT ST SPQ PQS team proactively engages within SHS IT across service/application teams in support of successful business results through projects and changes of services/applications.

The initial primary focus for new PQS team members in the GDC will be in supporting a very large, multi-year, SAP project to assure quality and regulatory compliance.   This includes ensuring quality deliverables meet the necessary standards across the service/application lifecycle, where authoring of IT documentation and testing help and other support is needed to reach successful results.

 

The PQS team member responsibilities also include sponsorship, design, and continual improvement of the quality and project management practices and metrics.  This includes the processes and tools used to execute these global standards, as well as, incorporation of / interface with / proposing of improvements for other topics, processes, and tools that support success that influence or are executed as part of projects and changes (E.g., demand management, change management, supplier management, requirements engineering, data privacy, export controls, software clearing, …).

Roles & Responsibilities:

 

·         Work with project/service/application teams to ensure global quality and project management standards are known and understood.

·         Assess gaps in understanding of global standards and support resolving any gaps through training, counseling, and/or planning.

·         Support development of global standard deliverables through authoring, reviewing, and approving as defined by the process.

·         Establish a trusted, value add relationship with the teams as assigned.

·         Propose improvements for global standards with a focus on digitalization and automation.

·         Apply LEAN principles in support of the principles of SHS.

·         Develop KPIs and measurements to track project performance and improvements.

·         Travel internationally on an as needed basis, based on assignments.

·         Other duties as assigned and necessary to ensure that SHS IT performs at the highest level and is providing value to our Business Partners.

 

 

 

 

Technical Skills Needed

  • Experience with regulatory and quality standards (e.g. specifically medical regulatory influences)
  • Experience with auditing practices
  • Experience working with various IT project management methodologies (especially Agile, SCRUM, and SAFe)
  • Experience working with IT system development lifecycle (e.g., requirements, system development, testing, production implementation)
  • Experience or basic understanding of LEAN principles, tools, and methods (e.g., value-focused mindset, A3 problem solving, Kanban, retrospectives)
  • Experience working within a global IT organization that supports a healthcare regulated environment of services and systems (e.g., having at least a basic understanding of FDA 21CFR and Part 11)
  • Experience supporting, as project manager, systems analyst, or quality manager, global IT systems where processes and regulations are embedded into the operational workflow (e.g., SAP)
  • Skills to support global IT regulatory requirements fulfillment (e.g., understanding of electronic records and signatures, data privacy, information security)
  • Experience in auditing documentation content and process compliance related to IT project management and application development
  • Experience in IT systems requirements engineering is preferred but not required.
  • Exposure in the SAP application and Solution Manager experience would be added advantage

 

 

 

 

 

Knowledge Needed

·         An understanding of PM and quality global standards – including processes and tools - this includes interfaces to other processes and compliance topics, like how requirements and testing are aligned to ensure optimal project performance and quality.

·         An understanding of foundational PM principles including management of scope, schedule, budget, risk, resources, quality, communications, suppliers, stakeholders, and team operations.

·         An understanding of SHS compliance topics to ensure effective execution within a project (e.g., data privacy, information security, …)

·         An understanding of contemporary PM principles including Lean, Scrum, and Agile.

 

 

 

 

Soft Skills Needed

·         Interpersonal skills to proactively build relationships and trust across project teams

·         Interviewing skills to proactively talk with individuals and groups, and to ask the right questions to surface essential PM needs

·         Listening skills to understand what people say and to detect what they might be hesitant to say

·         Analytical skills to critically and proactively evaluate the information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, abstract up from low-level information to a more general understanding, to effectively communicate guidance for PMs and support successful PM standards implementation

·         Facilitation skills to proactively provide PM with the necessary information for effective project execution across process and tools

·         Observational skills to proactively validate information obtained via other techniques and expose areas of gaps or areas for improvement

·         Problem-solving skills to contribute to resolutions necessary for project results

·         Leadership skills to foster teamwork and a collaborative environment focused on business results

·         Flexibility in a fast-paced changing environment with the ability to adapt to changes quickly

·         Writing skills to communicate information proactively and effectively to PMs and others across SHS IT with respect to the global PM standards

·         Organizational skills to work with the vast array of information gathered during project execution and to cope with rapidly changing project environment

·         Interpersonal skills to help negotiate priorities and to resolve conflicts for project teams

 

 

 

 

Measures of Performance

·         Evaluation from project management on overall quality and effectiveness of project execution

·         Feedback from key stakeholders on how the global standards were executed

·         Customer and project team satisfaction measures

 

 

 

 

 

 

 

Job ID: 188044

Organization: Siemens Healthineers

Company: Siemens Healthcare Private Limited

Experience Level: Experienced Professional

Job Type: Full-time

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