Job Description

POSITION: QUALITY MANAGER
s:
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 company's 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.

Requirements:

• Bachelor's or master's 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

Kindly contact Ms Rachel at +6019-772 2619 for further details or send your resume to [rachel.gan@cityrecruit.com.my]
or
Kindly contact Mr Edwin +6012 692 5453 or send your resume to [crcs-my-recruitment@cityrecruit.com.my]

Skills Required