Quality Manager

Pasir Gudang - Malaysia

Monthly Salary: Not Disclosed

Posted on: 5 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Summary:

The Quality Manager in the field of Medical Manufacturing plays a critical role in ensuring the highest standards of quality compliance and regulatory adherence across all aspects of the manufacturing process. This leadership position requires expertise in quality management systems regulatory requirements and continuous improvement methodologies. The Quality Manager is responsible for establishing and maintaining a culture of quality excellence while ensuring the safety and efficacy of medical products.

Duties & Responsibilities:

1. Quality Management System:

Develop implement and manage a robust quality management system (QMS) compliant with applicable regulations such as ISO 13485 and FDA guidelines.
Ensure that all manufacturing processes and procedures adhere to the established QMS.

2. Regulatory Compliance:

Stay current with medical device regulations standards and guidelines to ensure the companys products are compliant.
Lead regulatory audits and inspections interacting with regulatory agencies as necessary.
Collaborate with regulatory affairs to ensure timely and accurate submissions to regulatory authorities.

3. Quality Assurance:

Oversee and perform quality audits assessments and inspections to ensure adherence to quality standards.
Establish and maintain procedures for product testing validation and verification.
Drive continuous improvement initiatives based on quality data feedback and risk assessments.

4. Supplier Quality Management:

Manage the qualification assessment and auditing of suppliers to ensure the quality of incoming materials and components.
Collaborate with suppliers to address quality issues and drive corrective and preventive actions.

5. Risk Management:

Implement risk management processes to identify assess and mitigate risks associated with product quality and safety.
Ensure that risk management practices are integrated into the design and manufacturing processes.

6. Quality Metrics and Reporting:

Define and monitor key quality metrics to assess the effectiveness of the QMS and manufacturing processes.
Prepare regular quality reports for senior management highlighting trends challenges and improvement opportunities.

7. Training and Development:

Provide training to employees on quality standards regulations and best practices.
Foster a culture of quality awareness and accountability across the organization.

8. Cross-Functional Collaboration:

Collaborate with R&D manufacturing engineering and other departments to ensure quality considerations are integrated throughout the product lifecycle.
Work closely with production teams to resolve quality-related issues and implement corrective actions.

9. Leadership and Team Management:

Lead and develop the quality team providing guidance mentorship and performance evaluations.
Foster a collaborative and innovative team environment that encourages continuous learning and growth.

Minimum Qualifications:

Bachelors or masters degree in engineering Quality Management Life Sciences or related field.
Extensive experience (8 years) in quality management within the medical device or pharmaceutical manufacturing industry.
In-depth knowledge of relevant regulations and standards such as ISO 13485 FDA QSR and EU MDR.
Strong experience with quality tools and methodologies (e.g. Six Sigma Lean) to drive process improvement.
Proven experience in managing and leading quality teams.
Excellent problem-solving analytical and decision-making skills.
Effective communication skills to interact with cross-functional teams and regulatory authorities.
Strong project management skills and the ability to manage multiple priorities.
Certification in quality management (e.g. Certified Quality Manager Certified Quality Engineer) is a plus.

Salary Range: Up to RM12k

Location: Pasir Gudang

Job Summary: The Quality Manager in the field of Medical Manufacturing plays a critical role in ensuring the highest standards of quality compliance and regulatory adherence across all aspects of the manufacturing process. This leadership position requires expertise in quality management systems reg...