Senior Quality Engineer-QMS-Shanghai-00000N9U
Description
1. Principal Duties and Responsibilities (General Summary ，essential functions and authorities, etc.)
1. Support the manager to maintain and improve quality system compliance in JJMC & JJMS as per ISO13485: 2003, J&J Quality Policy, and regulatory requirements，focused on below items:
1.1. Management Review
Prepare management review, including maintaining procedure, drafting the review plan, collecting data for review, archiving records and tracking the MAP.
1.
1.1.
1.2. Quality Agreement
Maintain the quality agreements of JJMC/JJMS with relevant parties, including Franchise, distribution center, exporting countries and/or other affiliates, and organize to implement the stipulated requirements within the company.
1.3. CAPA
1.2.
1.3.
1.3.1. Track CAPA case, complete the dashboard and report any overdue case to QMS manager
1.3.2. Provide summary for management review and/or sourcing visit.
1.3.3. Participate CAPA investigation
1.4. Procedure Management
Review quality related procedures and ensure the compliance with external and internal regulation/standard of the content.
1.5. Supplier Management
1.5.1. Maintain supplier management procedure
1.5.2. Coordinate supplier management work, including the annual supplier audit plan.
1.5.3. Conduct supplier management work, including supplier audit and supplier evaluation work, together with other functions.
1.6 Quality Planning/Quality Policy/Quality Objective Management
1.6.1. Coordinate the quality planning activities within JJMS when necessary.
1.6.2. Maintain and communicate the quality policy.
1.6.3. Coordinate the establishment, breakdown, monitoring and measurement of the quality objectives.
1.7. Others
1.7.1. Support QMS manager for team-building work of Q&C department
1.7.2. Other responsibilities defined in written procedures.
2. Fulfill other tasks assigned.
3. Comply with EHS & ISO14001.
Qualifications
1. Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
- Bachelor degree on pharmaceutical, medicine, medical device or related subjects.
- 3-5 year experience in quality compliance or related areas in medical device or pharmaceutical industries.
- Good communication skills and leadership.
- English fluent in reading, writing, oral, listening.
- Familiar with routine operations of computer and software.
Primary Location:Asia Pacific-China-Shanghai-Shanghai
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Quality Assurance
Description
1. Principal Duties and Responsibilities (General Summary ，essential functions and authorities, etc.)
1. Support the manager to maintain and improve quality system compliance in JJMC & JJMS as per ISO13485: 2003, J&J Quality Policy, and regulatory requirements，focused on below items:
1.1. Management Review
Prepare management review, including maintaining procedure, drafting the review plan, collecting data for review, archiving records and tracking the MAP.
1.
1.1.
1.2. Quality Agreement
Maintain the quality agreements of JJMC/JJMS with relevant parties, including Franchise, distribution center, exporting countries and/or other affiliates, and organize to implement the stipulated requirements within the company.
1.3. CAPA
1.2.
1.3.
1.3.1. Track CAPA case, complete the dashboard and report any overdue case to QMS manager
1.3.2. Provide summary for management review and/or sourcing visit.
1.3.3. Participate CAPA investigation
1.4. Procedure Management
Review quality related procedures and ensure the compliance with external and internal regulation/standard of the content.
1.5. Supplier Management
1.5.1. Maintain supplier management procedure
1.5.2. Coordinate supplier management work, including the annual supplier audit plan.
1.5.3. Conduct supplier management work, including supplier audit and supplier evaluation work, together with other functions.
1.6 Quality Planning/Quality Policy/Quality Objective Management
1.6.1. Coordinate the quality planning activities within JJMS when necessary.
1.6.2. Maintain and communicate the quality policy.
1.6.3. Coordinate the establishment, breakdown, monitoring and measurement of the quality objectives.
1.7. Others
1.7.1. Support QMS manager for team-building work of Q&C department
1.7.2. Other responsibilities defined in written procedures.
2. Fulfill other tasks assigned.
3. Comply with EHS & ISO14001.
Qualifications
1. Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
- Bachelor degree on pharmaceutical, medicine, medical device or related subjects.
- 3-5 year experience in quality compliance or related areas in medical device or pharmaceutical industries.
- Good communication skills and leadership.
- English fluent in reading, writing, oral, listening.
- Familiar with routine operations of computer and software.
Primary Location:Asia Pacific-China-Shanghai-Shanghai
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Quality Assurance