Senior Quality Project Manager

Job Title

Senior Quality Project Manager

Job Description

The Senior Quality Project Manager plays an important role within Philips Image Guided Therapy Devices (IGTD) quality organization by leading complex, integral Quality projects from inception to market introduction/internal delivery, ensuring they meet organizational objectives and stakeholder expectations.

Your role:

• Manages multiple large-scale, complex, integral, full cycle projects of 1-2 years duration, ensuring adherence to timelines/budgets and ensuring successful outcomes that meet organizational objectives and stakeholder expectations.
• Sets strategic direction within the project(s) and related programs, aligning project goals with broader organizational objectives and ensuring that all project activities support the company's strategic vision.
• Leads and guides diverse, multi-disciplinary teams, promoting collaboration, efficiency, and effectiveness to achieve project goals and deliverables in a dynamic and often complex environment.
• Develops and maintains strategic partnerships with internal and external stakeholders, leveraging these relationships to support project success and negotiate effective solutions.
• Identifies and leverages organizational opportunities to create business value, aligning project goals with strategic objectives and continuously seeking areas for innovation and improvement.
• Monitors and balances project risks and issues, providing detailed escalation reports to senior management and ensuring proactive risk management and effective resolution of any challenges.
• Ensures adherence to Philips standards and best practices as defined in the Philips Business System (PBS) and the Philips Excellence Process Framework (PEPF), maintaining compliance and consistency across all project activities.
• Exhibits an advanced understanding and application of Philips PM Standards (PMBok and SAFe), ensuring that project management practices are aligned with organizational expectations and industry best practices, while continuously improving processes and methodologies.

You're the right fit if:

• You have a minimum of 7+ years’ experience in full-cycle, Quality Project management within FDA regulated medical device environments, and experienced in all aspects of E2E global Program/Project Management including cross-functional leadership, change/risk management, KPI’s, budgeting, timelines, resource allocation, project strategy, reporting, communication, etc.
• You have proven experience managing quality projects focused on Quality Process Engineering, receiving inspection, sterilization, calibration, chemical analysis, QMS/process/Testing standardization, training etc.
• You have detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), etc.
• You have proven experience utilizing Quality KPI’s/Data Analysis to assess project performance and identify process and continuous improvement opportunities.
• You’re able to effectively communicate, influence and build relationships with cross-functional team members, internal/external stakeholders at all levels, suppliers, and manage/facilitate FDA, competent authorities, Regulatory Agencies and Notified Body audits and inspections.
• You have a minimum of a Bachelor’s Degree (Required) in Engineering, Quality or related disciplines. PMP, PMBOK, SAFe certifications desired.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position

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How we work together:

We believe that we are better together than we are 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.

• This is an Office role.
• 1st Shift.

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 improve the lives of others.

• Learn more about our business

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• Discover our rich and exciting history.

• Learn more about our purpose.

• Learn more about our culture.

Additional Information:

• Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Alajuela, Costa Rica.

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