Philips Quality Engineer - CAPA Facilitator in Orlando, Florida

Quality Engineer (CAPA Facilitator)

Responsibilities include:

Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech focused company, you will be responsible for successfully working with Philips teams to ensure that Corrective and Preventive Actions demonstrate full documentation to ensure compliance to worldwide regulatory approval agencies such as the US Federal Drug Administration (FDA). CAPA facilitator provides comprehensive management and support of existing and potential issues resulting from quality concerns, customer complaints, audits, process deficiencies, etc. to assure continuous improvement.

Roles/Responsibilities

  • Provide CAPA support for step by step CAPA element execution

  • Ensure thorough documentation of the CAPA process from identification of problem through verification and validation of resolution (Effectiveness)

  • Ensure documentation of all essential elements of a fully compliant CAPA system: identification, evaluation, investigation, analysis, implementation, follow up and approvals

  • Monitor CAPA timelines to ensure on time CAPA closure. Own CAPA metrics, measure and report CAPA burn down progress to management

  • Have a “first time right” focus when defining CAPA timeliness and closure date commitments

  • Drive daily management boards (DMB)

  • SME audit support for CAPA’s

  • Support CAPA Review Board meetings

  • Provide guidance and support to CAPA owners on best practices (Continuous improvement)

  • Provide feedback to QMS for management reviews

  • Provide CAPA information to R&D for new product development programs

  • Provide input on CAPA improvement opportunities

  • Support other compliance initiatives as required

Requirements:

  • Bachelor’s degree in an Engineering or Science related field or equivalent technical experience.

  • At least 3 years of experience in Medical Device or regulated industry.

  • Strong Project Management skills, including ability to project manage and facilitate all CAPA activities.

  • Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.

  • Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.

  • Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels.

  • Able to understand and analyze complex problems, including software and hardware design issues.

  • Ability to analyze data and apply statistical techniques.

  • Excellent written and verbal communication skills.

In this role, you have the opportunity to:

  • Work within our Medical Consumables and Sensors Business Innovation Unit (MCS BIU) as Quality Engineer-CAPA Facilitator, to guide and support Business Groups, Markets and enabling functions to consistently do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.Our Medical Consumables & Sensors (MCS) Business Innovation Unit (BIU identifies and meets customer and market needs by designing, developing, and distributing consumable and sensor products that enable clinical measurement for Philips Healthcare and non-Philips patient monitoring solutions. MCS also designs, markets and distributes to customers around the world a portfolio of products that provide developmental care solutions in perinatal markets in addition to providing global customers specialized MRI compatible patient monitoring solutions, consumables and sensors.

You are responsible for:

  • Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech focused company, you will be responsible for successfully working with Philips teams to ensure that Corrective and Preventive Actions demonstrate full documentation to ensure compliance to worldwide regulatory approval agencies such as the US Federal Drug Administration (FDA). CAPA facilitator provides comprehensive management and support of existing and potential issues resulting from quality concerns, customer complaints, audits, process deficiencies, etc. to assure continuous improvement.

  • Provide CAPA support for step by step CAPA element execution

  • Ensure thorough documentation of the CAPA process from identification of problem through verification and validation of resolution (Effectiveness)

  • Ensure documentation of all essential elements of a fully compliant CAPA system: identification, evaluation, investigation, analysis, implementation, follow up and approvals

  • Monitor CAPA timelines to ensure on time CAPA closure. Own CAPA metrics, measure and report CAPA burn down progress to management

  • Have a “first time right” focus when defining CAPA timeliness and closure date commitments

  • Drive daily management boards (DMB)

  • SME audit support for CAPA’s

  • Support CAPA Review Board meetings

  • Provide guidance and support to CAPA owners on best practices (Continuous improvement)

  • Provide feedback to QMS for management reviews

  • Provide CAPA information to R&D for new product development programs

  • Provide input on CAPA improvement opportunities

  • Support other compliance initiatives as required

You are a part of:

As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit.

To succeed in this role, you should have the following skills and experience:

  • Bachelor’s degree in an Engineering or Science related field or equivalent technical experience.

  • A minimum of 3 or more years’ of experience in Medical Device or regulated industry.

  • Strong Project Management skills, including ability to project manage and facilitate all CAPA activities.

  • Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.

  • Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.

  • Demonstrated ability to collaborate with the business and effectively interact with and influence employees, and managers on all levels.

  • Able to understand and analyze complex problems, including software and hardware design issues.

  • Ability to analyze data and apply statistical techniques.

  • Excellent written and verbal communication skills.

In return, we offer you:

The unique professional challenges that our Quality Transformation presents. The empowerment to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world. The opportunity to inspire others to adopt the mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.

Why should you join Philips?

Working at Philips is more than a job. It is a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, and protected veteran or marital status.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Contact

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