PH QMS site Lead Shenzhen
PH QMS site Lead Shenzhen
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Job Description
Job Title
PH QMS site Lead - ShenzhenJob Description
Job Responsibilities:
Point of Contact for PH Shenzhen employees concerning QMS relevant topics
Takes ownership of preparing facilitating and/or hosting Internal and External Audits and follow-up. Own or support CAPAs to ensure that QMS is efficient and meets the regulatory requirements.
Works under limited supervision and broad guidelines regularly applying independent judgment on matters of significance to drive project success and compliance.
Contributes to the development implementation and revision of QMS processes including standard operating procedures (SOPs) work instructions and quality manuals ensuring their accuracy clarity and compliance with relevant standards.
Conducts risk assessments activities identifying potential risks to regulatory compliance quality and QMS integrity and developing robust mitigation strategies to minimize their impact.
Participates in continuous improvement initiatives within the QMS proposing and implementing enhancements to processes tools and systems to drive overall quality performance and operational excellence.
Applies specialized knowledge in breadth and/or depth to a variety of issues and projects within the team ensuring effective solutions and innovative approaches to complex challenges.
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.
Cultivates effective relationships with internal and external partners providing influence over projects and peer groups by demonstrating a comprehensive understanding of the area of specialization.
Leads cross-functional problem-solving sessions to address significant QMS issues utilizing structured methodologies like root cause analysis and driving the implementation of solutions.
Prepares for and participates in external regulatory audits and inspections by ensuring readiness of documentation processes and records and provide responses to audit findings in collaboration with stakeholders.
Minimum required Education:
Bachelors / Masters Degree in Mechanical Engineering Industrial Engineering Science or equivalent.
Minimum required Experience:
Minimum 2 years of experience with Bachelors in areas such as Quality Management Systems Quality Audits or equivalent in highly regulated environments/industries such as MD Pharma Automotive OR no prior experience required with Masters Degree.
Preferred Skills:
Regulatory Requirements (ISO9001 ISO13485 NMPA)
Quality Management Systems (QMS)
Project Management
Troubleshooting
Data Analysis & Interpretation
Process Improvements
Regulatory Compliance
Business Acumen
Proficient in Chinese and English in written and spoken words
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 companys facilities.
Field roles are most effectively done outside of the companys 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 wont 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 youre 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.
Employment Type
Full-Time
