Johnson & Johnson Careers

[Consumer] Senior Quality Engineer

Taipei, Taipei
Quality Assurance


Job Description

Requisition ID: 1805660928W

The position is designed to be providing overall quality leadership for EM and chemical / component / packaging material supplier quality activities, and local BLT team engagement to make sure imported and exported products, from product development through to commercialization and distribution comply in the manner with Regulatory, GMP, Safety Health and Environment and corporate quality standards. 
Major responsibilities are as following in accordance to STD, WWSP, Regional procedures, GMP related standards, and local Regulatory requirements: 
1. Manage EM of the following activities 
- Review validation protocol / result (mixing, filling, packing, C&S validation)– (will be transferred the role to SMP in 2013, waiting for the final announcement) 
- Issue/revise Quality Agreement and Product specifications as required in GSS 
- Dispatch new product / packing design FAI samples to receiving countries 
- Join audit with EM Q&C head to audit EM on yearly basis and EM APP follow up 
- Assist EM Q&C in conducting INV / complaint investigation 
- Monthly meeting with KNH 
2. Manage local suppliers used by regional team 
- Enhance supplier performance 
- Establish annual supplier audit schedule and follow up 
- Upload final audit report into Symphony audit module 
- NC investigation / rectification action implementation practices 
3. Complete APR Q&C section and make sure all documents are available 
- Final APR filing / management 
- Initiate imported product quality incidents to manufacturing site for quality improvement 
3. Manage change control process 
- Coordinate product related changes 
- Issue change notification to make sure related functions are notified and take properly actions 
4. Upload all INV / CAPA into Symphony 
- Make sure all INV cases are reported timely 
- For imported products, to follow up with manufacturing site to initiate action plan and ensure the case closure timely 
5. Attend BLT meeting monthly basis to support company business drive by brand 
- Ensure that NPI timeframe is reasonable (achievable) 
- Provide NPI product information manage by Q&C to BLT team members 
- Share launched product post review (share critical complaint or enquiry if any) 
- Initiate change notification and make sure all related functions know the follow-ups


Qualifications

Requirements 
- Strong leadership, influence, collaboration, and interpersonal skills. 
- Knowledge of cGMPs / GWP / GDP and Quality Systems. 
- Analytical and process oriented with an interest/aptitude in operations. 
- Communication and presentation skills 
- Decision Making / Problem Solving 
- Process Excellence skills & experience


Primary Location
Taiwan-Taipei-Taipei
Organization
Johnson & Johnson Taiwan, Ltd. (8580)
Job Function
Quality Assurance
Requisition ID
1805660928W