Manager, Quality

4 days ago

Pasir Gudang, Malaysia Masimo Full time

**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 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.

**Minimum & Preferred Qualifications and Experience**:
**Minimum Qualifications**:

- 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

**Preferred Qualifications**:

- Not applicable

**Education**:
Bachelor’s or master’s degree in engineering, Quality Management, Life Sciences, or related field.

Physical requirements/Work Environment

This position primarily works in an office and manufacturing/production environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described

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