Quality Manager | Medical Industry

Masimo.; Johor Bahru; In loco; MYR 180.000 - 300.000; Tempo pieno

Descrizione del lavoro

Masimo is seeking a Quality Manager in Medical Manufacturing to lead the quality management system, regulatory compliance, and continuous improvement across the manufacturing process.

The role requires extensive experience with ISO 13485, FDA QSR, and EU MDR, plus proven leadership of quality teams and cross-functional collaboration to ensure safety and efficacy of medical products.

Competenze

• Requires knowledge of ISO 13485, FDA QSR, and EU MDR.
• 8+ years of quality management experience in medical device/pharma manufacturing.
• Proven experience leading quality teams and driving process improvements.
• Certification in quality management is a plus (e.g., CQE, CQMgr).

Mansioni

• Develop, implement, and maintain a robust QMS compliant with regulations.
• Lead regulatory audits and interactions with authorities.
• Oversee quality audits, inspections, and product testing procedures.
• Manage supplier qualification, assessment, and CAPA activities.
• Implement risk management across design and manufacturing.
• Define quality metrics and prepare senior management reports.
• Provide training on quality standards and foster quality culture.
• Collaborate with R&D, manufacturing, and regulatory affairs to integrate quality throughout the lifecycle.

Conoscenze

Problem-solving

Analytical thinking

Decision-making

Effective communication

Project management

Cross-functional collaboration

Quality leadership

Formazione

Bachelor’s or Master’s degree in engineering/Quality Management/Life Sciences

Strumenti

Six Sigma

Lean

QMS tools

Descrizione del lavoro

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.

Minimum & Preferred Qualifications and Experience

• 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

Education

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

Masimo (NASDAQ: MASI) headquartered in Irvine, California, is a fast-growing and award-winning international medical technology and device company with operations spanning the globe. We develop innovative, noninvasive monitoring technologies that save, extend and improve the lives of people of all ages, in all walks of life. These revolutionary technologies are helping to solve "unsolvable" problems that have plagued the healthcare industry, while taking the pain and discomfort out of blood monitoring. For almost 20 years, innovation has been and will continue to be our passion.