Senior Specialist - Quality - Medical Device

Only candidates from Medical Device Company needed

1. Distributor Center Quality Management :

a) Implement and maintain Label Management Process and Over-Labeling Process at 3PL, to eliminate Quality Risk related to Local Over-Labeling Activities.

b) Implement and maintain Product Inspection Process and Product Release Process, including Imported Finished Goods, Over-Labeled Products, and Returned Products. Support business by releasing the product in timely manner

c) Implement and track Quality Hold in 3PL

d) Drive improvement for 3PL Quality Management System, implement and maintain Quality Agreements

2. Distributor Management :

a) Work as an expert in Auditing process

b) Manage of Edwards Distributor Management Program

c) Qualification of New Distributor

d) Maintenance of existing distributor

e) Lead Distributor Audit, follow up for CAPA Response plan, tracking the action plan till the closure

f) Develop Distributor Training Material

g) Induction Training for new distributor and refresher training for existing distributor

3. Participation in Internal/Supplier Audit :

a) Participate in internal and external audit program or act as auditee

Marginal Job Functions :

4. Other incidental duties : Implement continuous improvement program or project assigned by manager
 
Skills required :

- Master/Bachelor's degree in science field required. ISO13485 lead auditor certification is must.

- 4-6 years of previous related experience required

- Experience working in a medical device, healthcare, or a related environment preferred

- Proven expertise in MS Office Suite

- Excellent written and verbal communication skills in Local Language including negotiating and relationship management skills

- Strong written and verbal communication skills in English

- Strong problem-solving and critical thinking skills

- Full knowledge and understanding of quality management systems/Good Distribution Practices/Good Storage Practices

- Full knowledge of medical or pharmaceutical regulations as relating to documentation (e.g. Good Documentation Practices)

- Full understanding of medical devices regulations (e.g., ISO13485, Drug & Cosmetic act, India Regulatory Requirements and regulatory requirement of other Asia Pacific countries)

- Strict attention to detail

- Ability to interact professionally with all organizational levels

- Ability to manage competing priorities in a fast paced environment

- Work is performed independently on more complex projects and/or lines of work and reviewed for accuracy and soundness