[MedTech] Senior Commercial Quality Specialist

Overall purpose of job:

This position is responsible for ensuring, overseeing, and carrying out tasks and projects related to maintaining

quality & regulatory compliance activities at DC in Taiwan for Medical Devices as required by Johnson & Johnson

Quality and Compliance requirements as well as Taiwan regulatory requirements.

Main responsibilities are as follows:

• Implementing, maintaining, and evaluating a highly effective and compliant quality processes for Taiwan

DELIVER operations

• Independently partnering with regional/global Commercial Quality teams, other functional groups, and

operational leaders

• Close collaboration with Commercial Business Units, Regulatory Affairs, and Supply Chain, etc.

Essential duties and responsibilities:

• Ensuring TW MD DCs meets all appropriate related requirement such as: regulatory authority, and sector

requirements.

• Support and maintain regional Q&C DELIVER Dashboard as per agreed target

• Implement and support Quality System implementation within the scope of DELIVER, includes ensuring TW

sites meet DELIVER DC QSCAN, GWP requirements and conducting audit to 3PL as well as ensure satisfactory

closure of AAP of 3PL.

• Established quality agreement at all TW JNJ TPL for warehousing, transportation and other 3rd party services

related.

• Flawless execution on global standard requirement associated with TPL.

• Ensure timely JNJ DC quality reviews are conducted and actively participate on management review

• Maintain and monitor system compliance such as for NC/CAPA, training program, change controls owned by

DELIVER

• Responsible for overseeing the product return and inbound discrepancy process.

• Partners with DELIVER Operations to implement business solutions and leads compliance efforts associated

with complex projects and activities through effective implementation of the Audit Action Plan (AAP) process

• Supplier Audit program and ensure inspection readiness and provide strategic focus for quality and

compliance by working with appropriate functional areas to identify continuous improvement opportunities

• Coordinates and reports timely and accurate metrics and analysis per J&J policies. Reporting responsibilities

within TW include (but are not limited to): Metric evaluation and reporting in CURVE entry updates.

• Accountable for Quality management of repacking, relabeling, over labeling, and reworking operations

conducted within the DC.

• Accountable for accurate and timely communication of temperature control excursions occurring within the

DC to appropriate partners

• Ensure the material & product control within DC, including stop shipmen, return goods, inbound discrepancy.

stop shipment

• Act as qualified trainer to deliver training on J&J processes

Special requirements:

1. More than 6-year experience in QC or QA Function of any Medical devices or Pharmaceuticals Industry.

2. Bachelor’s Degree in Science (Life Sciences, Microbiology, etc) or Engineering required.

3. Good knowledge of Good Distribution Practices (GDP), GMP and validation- demonstrated knowledge and

application of QSR, ISO9001, ISO13485 and other international standards.

4. Certified Auditor of GMP, ISO 9001, or ISO 13845 preferred

5. At least 20 hours of training in past five years on the following topics:

• Local laws and regulation of Medical Device Good Distribution Practice

• Medical Device Quality Management System Regulations

• Knowledge on preparation and process on medical device registration and market approval

6. Manage document on medical device product source and flow

7. Knowledge of manufacturing environment or repackaging/relabeling environment.

8. Fluency in English language required.

Job Requirements

Essential knowledge and skills:

1. Good knowledge of Good Distribution Practices (GDP), GMP and validation- demonstrated knowledge and

application of QSR, ISO9001, ISO13485 and other international standards.

2. Certified Auditor of GMP, ISO 9001, or ISO 13845 preferred.

3. At least 8 hours of training annually on Medical Device Industry for local laws and regulations and QMS

regulations for Medical Devices.

4. Knowledge of manufacturing environment or repackaging/relabeling environment

5. Fluency in English language required.

6. Demonstrated knowledge and experience in quality or operations function.

7. Task oriented with proven experience in the delivery high quality work

8. Proficiency in Microsoft Office (PowerPoint) other tools required to develop training materials

9. Excellent analyzing / decision making ability

Core competencies required for this role:

1. Strong communication skills

2. Strong work ethic, integrity, and respect

3. Customer (internal and external) driven approach

4. Exercises Good Judgment and drives changes in continuous changed regulatory environment