Quality Systems Validation Specialist

Job Description

Job Title: Quality Systems Validation Specialist

Job Responsibilities:

• Provide dayu2011tou2011day support for the validation lifecycle management application to end users, demonstrating clear communication, responsiveness, and a customeru2011first approach while maintaining compliance expectations

• Coordinating and supporting the deployment of new functionality to current users

• Communicating to the user community and stakeholders, performing validation implementation activities, mailbox management, and escalations, as necessary

• Communicating production issues to the Business Support Lead, performing root cause analysis, and strategizing resolution and workarounds for key users

• Supporting the development, maintenance, and delivery of software application training content

• Participating in establishing and delivering the NPSS Software Validation Training Curriculum per the training strategy and updating content as required based on changes to relevant regulations, internal processes, or tools which supports its execution

• Ensuring that tools, training, procedures, and work instructions are aligned and remain in a state of control.

• Participating in the communities of practice and other communication vehicles such as the NPSS Software Management CoE intranet site to ensure users of the NPSS Software Validation Process have access to the necessary resources to capably execute the process

• Supporting continuous improvement of relevant business processes

You are part of

The Shared Services organization supporting the NPSS Software Management Center of Excellence.u00A0 NPSS Business Support plays a pivotal role in ensuring that our front-line support for validation lifecycle management, serves our customers with speed and excellence and that the users are trained according to their role.

To succeed in this role, youu2019ll need a customer-first attitude and the following

• Bachelor's degree in Engineering required

• 8-10 years of experience working in disciplined regulated industry (Medtech/Pharma) in the application of automated technology, particularly 21 CFR Part 11 & Part 820, ISO 13485, GAMP 5

• Experience supporting ValGenesis software preferred

• Strong working knowledge of software validation and change management

• Experience with business application implementation projects, including being an active contributor on projects with scheduled deliverables

• Experience in Power BI, Power Automate, AI experience preferred

• Demonstrated ability to interact and communicate (both oral and written) in Standard English, including demonstrable writing skills, speaking, and comprehension ability to communicate across levels of the organization

• Demonstrated ability to communicate complex quality and system concepts clearly to both technical and nonu2011technical audiences

• Strong customeru2011focused mindset with the ability to balance compliance requirements and business needs

• Proven collaboration skills, including the ability to work effectively with IT, quality, and business stakeholders

• Strong organizational and prioritization skills in a fastu2011paced, regulated environment

• Ability to influence without authority and drive issues to resolution

Minimum required Education:
Bachelor's Degree

Minimum required Experience:
Minimum 8-10 years of experience with highly regulated environments/industries such as Medical Device or Pharma

Preferred Skills:
u2022 Regulatory Requirements
u2022 Quality Management Systems (QMS)
u2022 Project Management
u2022 Troubleshooting
u2022 KPI Monitoring and Reporting
u2022 Data Analysis & Interpretation
u2022 Process Improvements
u2022 Technical Writing
u2022 Agile Methodology
u2022 User Training & Support
u2022 Training Content Development
u2022 Regulatory Compliance
u2022 Business Acumen

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the companyu2019s facilities.
Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 locations.
Indicate if this role is an office/field/onsite role.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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If youu2019re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .