Job Description

Job Title : Executive-Quality Assurance/Regularly Affair

Position Type: Regular

Department: Quality Assurance/Regularly Affair - CL

Location: Mohali

Number of Posts: 1

Industry Type: Medical Device Manufacturing

Qualification & Experience:

• Degree/Diploma in electronics with 2-4 years of experience in manufacturing industry.
• Should have hands on exposure to ERP system.
• Should be able to train & manage team activities under this profile.

Job Responsibilities :

• Prepare the Quality Management System Documents (Quality Manual, SOP, WI and Formats as applicable) as per applicable standard.
• Define Quality objectives for function and roles in consultation with top management.
• Ensure awareness of quality policy throughout the organization by suitable means.
• Implement QMS Documents for each process/function.
• Ensure that all documents are legible and signed by appropriate person.
• Reporting to top Management on the effectiveness of the quality management system and any need for improvement.
• Prepare and maintain master list of documents.
• Change /Modify documents on request through DCN (Documents Change Note).
• Ensure that changed/modified document is reviewed and approved by same role as original documents.
• Ensure that all circulated documents are controlled copy of master documents.
• Ensure the promotion of awareness of applicable regulatory requirements and quality management.
• Conduct internal audits as per QMS and ensure corrective actions against all non-conformances. Also conduct surprised/unannounced audits to check effective working QMS.
• Identify training needs in consultation with respective HOD's and coordinate trainings as required.
• Plan and conduct the MRM at defined intervals after internal audit.
• Follow-up with certification bodies for initial/surveillance audits.
• Provide and implement corrective actions against non-conformances reported in external audits.
• Keep updated on latest revision of applicable standards and align documents accordingly.
• Monitor quality objectives of roles and functions, and discussed with top management for action.
• Ensure compliance with Quality Management System (QMS) requirements and regulatory standards applicable to medical devices/any other product categories, including maintaining accurate detailed documentation, and records related to compliance activities
• Any other responsibility assigned from time to time by Management.

Key Skills:

• Should be Result oriented to achieve set targets
• Should have Good communication skills
• Should be disciplined and Punctual.

Job Types: Full-time, Permanent

Pay: ?9,486.88 - ?40,897.00 per month

Benefits:

• Provident Fund

Schedule:

• Day shift

Supplemental Pay:

• Performance bonus
• Yearly bonus

Experience:

• total work: 1 year (Preferred)

Work Location: In person