QMS Manager - Non Product Software Validation

Job Title

QMS Manager - Non Product Software Validation

Job Description

Job Title: QMS Manager - Non Product Software Validation

Job Responsibilities:
• Develop, implement, and maintain software validation procedures and standards

• Ensure non product software validation lifecycle is followed compliantly, including planning, risk assessments, testing and periodic review

• Ensure validation deliverables meet regulatory, quality and business requirments
• Prepares for and supports internal and external audits and inspections by ensuring all necessary documentation is available and providing detailed responses to audit findings.
• Facilitates cross-functional collaboration to resolve quality-related issues, working closely with other departments to ensure alignment and effective problem-solving.
• Oversee quality assurance processes related to computerized systems and software applications
• Review and approve validation documentation, including requirements specifications, test protocols, test reports, and validation summaries
• Drives continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to improve overall quality performance and operational efficiency.
• Addresses difficult to moderately complex issues or problems, requiring the evaluation of identifiable factors, following established processes and operational policies in selecting methods and techniques for obtaining solutions.
• Guides and mentors, the validation project team members, actively contributing to employee development in Validation Lifecycle requirements
• Participates in training sessions to stay updated on quality standards and QMS procedures, actively engaging in learning opportunities to enhance understanding of industry regulations and best practices.

Minimum required Education:
Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.

Minimum required Experience:
Minimum 8-10 years of experience in areas such as Quality Management Systems, Quality Audits or equivalent in highly regulated industry.

Preferred Skills:
• Regulatory Requirements

• Quality Management Systems (QMS)
• Project Management
• Data Analysis & Interpretation
• Process Improvements
• Technical Writing
• Computer System Assurance Validation
• Agile Methodology
• Training Content Development
• Regulatory Compliance
• 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 company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ 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.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re 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 here.