PH QMS site Lead - Shenzhen

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 CAPA's 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:

Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.

Minimum required Experience:

Minimum 2 years of experience with Bachelor's 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 Master's 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 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.