Head of Quality - Malacca City - Crowe Malaysia PLT

Head of Quality - Malacca City - Crowe Malaysia PLT

3 days ago

Description

Head of Quality Position Overview

We are seeking a highly experienced and skilled Head of Quality to lead our manufacturing quality team for the Surgical & Clean Room Business Unit.

Job Summary

The successful candidate will drive strategic direction and operating plans for our manufacturing operations, champion quality culture and mindset across the organization, and ensure that our products meet the highest standards of quality. Key responsibilities include ensuring compliance with regulatory requirements through proactive approaches and promoting best practices in quality.

Key Responsibilities

1. Technical Responsibilities:
2. Ensure regulatory compliance through proactive approaches.
3. Promote quality best practices and foster a quality-oriented culture.
4. Analyze industry trends, customer requirements, and business objectives to develop guidelines and methods.
5. Establish processes for managing customer complaints, change management, process validation, and core quality metrics.
6. Management Responsibilities:
7. Serve as a coach to plant QA Leads.
8. Support Plant QA to ensure harmonization of QC labs, effective budgeting, smooth operations, and collaboration with Plants Operations, Regulatory, R&D, and Commercial teams.
9. Act as a trainer or SME for Ansell Core Quality procedures.

Requirements

1. Minimum 8 years of relevant experience in glove manufacturing or medical device industry.
2. Good knowledge in 6-Sigma, ISO13485, FDA, Medical device regulations, and GMP.

Compensation

The salary range for this position is $120,000 - $180,000 per year.