WE ARE HIRING | QA MANAGER

Teleflex; Chennai; In loco; INR 3.500.000 - 6.000.000; Tempo pieno

Descrizione del lavoro

Teleflex Medical Private Limited in Puducherry is seeking an experienced Quality Assurance Manager to lead our QA function at the manufacturing site. The ideal candidate will drive QMS, regulatory compliance, audits, CAPA, and a culture of quality across the organization.

The role requires deep knowledge of medical device standards, EU MDR 2017/745, and ability to collaborate with regulatory authorities, Notified Bodies, and cross-functional teams.

Competenze

• Experience in Quality Management Systems for medical devices.
• Strong regulatory compliance knowledge for EU MDR 2017/745.
• Experience in audits, CAPA, customer complaint handling.
• Ability to drive continuous improvement and quality culture.
• Experience liaising with regulatory authorities and Notified Bodies.
• Proficiency in Tamil and English.

Mansioni

• Establish and maintain QMS in line with medical device standards.
• Lead management reviews and QA objectives.
• Ensure compliance with EU MDR 2017/745.
• Oversee product quality, inspections, and release.
• Manage customer complaints, adverse events, recalls, CAPA.
• Plan internal audits and coordinate Notified Body audits.
• Ensure document control and regulatory compliance.
• Drive quality improvements using SPC and process capability.
• Coordinate with Regulatory Affairs on licences and submissions.
• Promote quality awareness and training.
• Lead quality training and continuous improvement initiatives.

Conoscenze

Quality Assurance

Regulatory compliance

Audits

CAPA

QMS

Leadership

Tamil language

Descrizione del lavoro

Teleflex Medical Private Limited is looking for an experienced and dynamic Quality Assurance Manager to lead our Quality Assurance function at our Puducherry manufacturing facility.

The ideal candidate will have strong experience in Quality Management Systems, medical device regulatory compliance, customer quality, audits and continuous improvement, with the ability to drive a strong quality culture across the organization.

Key Responsibilities

• Establish, maintain and ensure compliance with the Quality Management System (QMS) in line with applicable medical device standards and regulatory requirements.
• Lead Quality Management Reviews and drive corporate and site-level Quality Assurance objectives.
• Ensure compliance with EU Medical Device Regulation (MDR 2017/745), including applicable PRRC responsibilities.
• Oversee product quality, incoming material inspection, in-process quality control, and final product release.
• Drive customer complaint management, adverse event reporting, product recalls, non-conformance and CAPA.
• Plan and lead internal quality audits and coordinate external and Notified Body audits.
• Ensure effective document control, technical documentation and regulatory compliance.
• Drive quality improvement initiatives using statistical process control and process capability methodologies.
• Coordinate with Regulatory Affairs and relevant authorities on manufacturing licences and regulatory submissions.
• Promote quality awareness and ensure customer and regulatory requirements are understood across the organization.
• Lead quality training and continuous improvement initiatives.

Ideal Candidate Profile

• Strong experience in Quality Assurance within the Medical Device Manufacturing Industry.
• Thorough understanding of Quality Management Systems and medical device regulatory requirements.
• Hands-on experience in audits, CAPA, customer complaint management and regulatory compliance.
• Knowledge of EU MDR 2017/745 and relevant medical device regulatory frameworks.
• Experience in managing quality teams and interacting with regulatory authorities and external auditors.
• Strong leadership, analytical, problem-solving and stakeholder management skills.
• Should be able to speak in Tamil ( Must) & English

Work Location: Teleflex Medical - Puducherry

Experience: Minimum 15 years