Medical Device Quality & Compliance Lead

Role Objective :

A key objective of this position is to design, implement and enhance organizational work practices that align with quality management principles. Role will focus on establishing a culture of continuous improvement, compliance and operational excellence within the organization. Role involves the development and maintenance of a Quality Management System (QMS), managing training initiatives and driving projects related to quality and regulatory compliance within the medical device sector.

Desired Candidate Profile :

• Detail-oriented professional with 15 to 18 years of experience in Quality Assurance or related fields, preferably within the Medical Device Industry.
• Strong understanding of regulatory requirements, including FDA, ISO 13485, GMP and GDP.
• Proven expertise in developing and implementing QMS processes, handling compliance, and conducting internal audits.
• Demonstrated ability to lead quality-based projects and manage cross-functional teams.
• Excellent communication and leadership skills, with a track record of successful project management and stakeholder engagement.

Responsibilities :

Quality Management System (QMS) Development :

Compliance & Documentation :

Audit & Risk Management :

Project Leadership :

Business Continuity & Process Improvement :

Training & Development :

Functional Skills Required :

Behavioral Skills Required :

Team Size to be Handle :

A minimum of 4 to 5 years of Medical Device QA experience will be advantageous.

Important Links :

Website : https : / / biotechhealthcare.Com /

LinkedIn : https : / / www.Linkedin.Com / company / biotechhealthcare /

Instagram : Biotech Vision Care

Biotech is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.