宜昌招聘

职位描述：
Principle QA Specialist


1. Position Summary:
The position is accountable for regulatory compliance and quality system management within supply chain management (SCM) and technical service center (TSC). This person will be the point person and accountable for execution of medical device GMP&GSP related regulation and corporate requirements in support of SCM&TSC. S/he will support the regulation and quality system objectives and strategies, regulatory and compliance requirement changes.


2. Principal Accountabilities:
- Manage regulatory compliance and quality management system within supply chain management (SCM) and technical service center (TSC).
- Performs and provides guidance and/or assist in defining, implementing and follow-up of GMP&GSP systematic regulation and corporate requirements within SCM&TSC operation.
- Conduct medical device risk analysis and develop quality control plan for product incoming receiving, in-process, finished products, labeling, storage, dispatch within SCM.
- Conduct medical device risk analysis and develop quality control plan for equipment product management within TSC.
- Development and implementation of QMS procedures, lead QMS continual improvement initiatives within SCM&TSC.
- Ensures that quality management tool/methods for analyzing data to evaluate the current process and process changes.
- Plans and conducts the analysis, investigation, inspection, and/or test of product nonconformance.
- Lead and/or support CAPAs investigation and follow up within SCM &TSC as required.
- Lead quality improvement activities by working closely with SCM & TSC for regulation and core requirements changes.
- Communicates significant quality issues or developments identified during quality activities and provides recommended process improvements to management.
- Provide support for 3rd party audits (CFDA, Notified Body) within QA/SCM/TSC.
- Maintains a working knowledge of government and industry quality codes and standards.


3. Experience:
- Medical device industry 5+ years quality experience
- 3-5 years of practical medical device manufacturing experience preferred.
- Working knowledge of CFDA medical device GMP&GSP regulations and how to interpret and monitor them with experience or knowledge in Quality Systems relating to medical device GMP&GSP and ISO.
- Understanding and implementation experience in the following tools is preferred: FMEA, control plan design, process capability improvement, 5S, kaizen, kanban, value stream management, poka-yokes, etc.


4. Education
- The candidate should have a Bachelor’s Degree in related life science or advanced technical degree or equivalent.


5. Job Competencies:
- Strong understanding on China medical device GMP and GSP requirements.
- Prior knowledge and understanding of the Medical Device or equivalent regulated industry, Quality Systems is preferred.
- The ability to lead a cross-functional team is required.
- Fluent oral and written English 举报 分享

About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.