HireDiversity

Shanghai, CN

Quality Engineer-QMS&DC-Shanghai-000008CM

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. CAPA
1.1.1. Maintain CAPA procedure.

1.1.2. Track CAPA case, complete the dashboard and report any overdue case to QMS manager
1.1.3. Provide summary for management review and/or sourcing visit.
1.1.4. Participate CAPA investigation

1.2. Change Control

1.2.1. Maintain change control procedure.
1.2.2. Track change case, complete the dashboard and report any overdue case to QMS manager
1.2.3. Provide summary for management review and/or sourcing visit.
1.2.4. Participate change case discussion

1.3. Risk Management

1.3.1. Maintain risk management procedure.
1.3.2. Provide training to process owner to complete the necessary FMEA report

1.4. Other responsibilities defined in written procedures.

2. Fulfill other tasks assigned.

3. Comply with EHS & ISO14001.

Qualifications


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.
- 1-3 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