Quality System Engineer
In this role, you have the opportunity to
- Be in the Zhuhai factory Operations PQMS organization to support the transformation activities of Factory.
- A major focus of this position will be working within a global network to address and Quality System improvements, training initiatives, Software Controls applicable to the US, Canada and EU related to non-product software systems
You are responsible for
- Define and maintain the Quality Management System procedures to ensure compliance to Philips Policies, ISO 9001, ISO 13485, 21 CFR 803, 806 and 820, Canadian Food, Drugs, and Medical Devices Regulations (CMDR) and EU Medical Device Regulations.
- Maintain, enforce, and manage a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes at all levels.
- Manage PQMS/PEPF related deployments and implementations.
- Ensure all mandatory training requirements are set and training is executed as required.
- Administer both profiles and training records in line with regulatory requirements.
- In close cooperation with supervisors and QMS management, administer profiles for all jobs with respect to job effectiveness / qualification, as well as QMS / Regulated Training Management.
- Ensure Training Management System set-up.
- Control and administer all trainings assigned to users in compliance with the applicable requirements.
- Ensure the addition and management of any local QMS documents in line with the evolution of the PQMS Trainings.
- Ensure training and training registration as per the QMS and generates training content for local QMS documents as necessary.
- Define and establishes a lean practice (tools, methods, standards, competency, process and process performance) for SW validation & lifecycle control of new and existing SW systems.
- Executes and /or manages SW validation & control activities.
- Ensures the accuracy, completeness and compliance of SW validation deliverables by reviewing the SW validation packages of SW applications, which automate Quality System processes.
- Author, reviews and/or approves SW validation deliverables for non-product SW, including but not limited to SW validation plans, requirements, test plans/protocols/results, risk assessments, traceability matrix and summary reports.
- Work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.
- Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
You are a part of:
- Philips Quality and Regulatory Team, it has recently restructured its organization to ensure you and your department have clear collaborates 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. As part of this new structure, you are empowered 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.
To succeed in this role, you should have the following skills and experience
- Bachelor’s degree in a scientific or technical field
- 2+ years of experience in Quality system management or Engineering/production functions with process validation (non-product software system) related knowledge or experience, experience in medical device industry preferred.
- Working knowledge of GMP’s and other FDA regulations, Experience in FDA Remediation projects-preferred
- Experience validating application activities.
- Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues.
- Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
- Strong IT skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications.
- Proven analytical capabilities
- Excellent communication, organizational and project management skills
- Successful experience working with cross functional teams across multiple work locations
- Effective written and oral communications skills and computer skills required
- Network oriented and able to interact with different business functions and can work within numerous systems
- Work cooperatively in a team environment
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Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven.
Little did they realize that it would become a global force of innovation, committed to
improving billions of lives worldwide. But it did.
Today, Philips is a world leading health technology company with a vision to make life better
for people worldwide through meaningful innovation. Making good on this promise depends on our
passionate, inspirational, collaborative and diverse team.
We have over 80,000+ brilliant people around the world but are always looking for more.
Like-minded, motivated, focused minds to join us in creating a healthier, more connected society
while tranforming themselves personally and professionally.
Working at Philips is more than a job. It's an experience filled with unexcepted moments that
will transform you in lasting and positive ways. Help us improve the world for the better while
building a career that no one could have planned for. Even you.