System Specialist ( ISO 13485:2016 )

Job Description

Title: System Specialist ( ISO 13485:2016 )

Company Name: WellMed Company Limited

Vacancy: 2

Age: 30 to 45 years

Job Location: Gazipur (Gazipur Sadar)

Salary: Negotiable

Experience:

• At least 5 years
• The applicants should have experience in the following business area(s): Medical Equipment

• Bachelor of Science (BSc)

• At least 5 years
• The applicants should have experience in the following business area(s): Medical Equipment

• Age 30 to 45 years

• Ensure all Quality policies, SOP, procedures, and work instructions are documented.

• Maintain all key area SOP and flow charts.

• Make Power Point presentations for monthly management quality review meetings & maintain employee training program according to the training calendar.

• Develop, implement and manage key performance indicators (KPIs) for each area of responsibility.

• Should have sound knowledge to implement ISO 13485:2016 standard as per buyer requirement.

• Implement appropriate quality procedures in every section. Regularly train the QC/QA team to consistently follow quality SOPs and ensure continuous improvement.

• Report all types of Quality Metrics and KPIs.

• Monitor risk assessment, quality gap and drive by using process mapping and other applicable tools.

• Conduct root cause analysis for defects and implement corrective action plans.

• Check production plan, execution, ensure all delivery challan, testing report of all product to confirm quality conformance as well as any unauthorized activities.

• Observe & escalate evidence of breaches of customer product safety and quality manual (customer manual, GOTS, OCS, OEKO-TEX, EU regulation law, AQL standard, etc.)

• Doing internal QMS/ Technical Audit being internal auditor, work with all section head for improvement.

• Train up all quality inspectors, and quality staff about basic quality requirements, quality concepts, and quality policy.

• Any other assignment as assigned by the top management.