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Job Summary:
This role leads quality management activities, ensuring product excellence from initial development through mass production. The position demands expertise in regulatory compliance (ISO 13485, FDA), process validation, and continuous improvement methodologies.
Key Responsibilities:
Quality Leadership
- Direct the team in resolving quality deviations, implementing timely corrective actions.
- Ensure adherence to ISO 13485 and applicable regulatory requirements (e.g., FDA).
- Oversee product quality throughout the entire lifecycle, from new product introduction (NPI) to full-scale production.
Quality Systems and Control
- Develop and maintain quality control plans for processes and products.
- Monitor and report key performance indicators (KPIs) for both internal and external quality.
- Drive continuous improvement initiatives to enhance customer satisfaction, company performance, and supplier quality.
- Create and manage internal quality systems, procedures, work instructions, and quality standards.
Auditing and Compliance
- Lead process and product audits, and manage follow-up improvement actions.
- Ensure compliance with industry standards (ISO 9001, ISO 13485), and conduct compliance and safety audits.
- Manage engineering changes (ECs), ensuring accurate and timely implementation of internal and external modifications.
General Duties
- Complete assigned tasks from superiors and contribute to quality strategy implementation.
Required Knowledge, Skills, and Abilities:
- Proficient in quality tools, ISO and IPC standards, and process validation.
- Experience coordinating and executing IQ/OQ/PQ process validation.
- Ability to utilize software for data analysis and reporting.
- Strong understanding of product and manufacturing processes.
- Knowledge of the business unit and its impact on customer satisfaction, product quality, delivery, and profitability.
- Expertise in quality tools (FMEA, PMP, SPC, 8D) and methodologies (Six Sigma, Lean Kaizen).
- Excellent communication skills for interacting with internal and external stakeholders.
- A preferable candidate is from the medical device manufacturing industry
Job Summary:
This role leads quality management activities, ensuring product excellence from initial development through mass production. The position demands expertise in regulatory compliance (ISO 13485, FDA), process validation, and continuous improvement methodologies.
Key Responsibilities:
Quality Leadership
- Direct the team in resolving quality deviations, implementing timely corrective actions.
- Ensure adherence to ISO 13485 and applicable regulatory requirements (e.g., FDA).
- Oversee product quality throughout the entire lifecycle, from new product introduction (NPI) to full-scale production.
Quality Systems and Control
- Develop and maintain quality control plans for processes and products.
- Monitor and report key performance indicators (KPIs) for both internal and external quality.
- Drive continuous improvement initiatives to enhance customer satisfaction, company performance, and supplier quality.
- Create and manage internal quality systems, procedures, work instructions, and quality standards.
Auditing and Compliance
- Lead process and product audits, and manage follow-up improvement actions.
- Ensure compliance with industry standards (ISO 9001, ISO 13485), and conduct compliance and safety audits.
- Manage engineering changes (ECs), ensuring accurate and timely implementation of internal and external modifications.
General Duties
- Complete assigned tasks from superiors and contribute to quality strategy implementation.
Required Knowledge, Skills, and Abilities:
- Proficient in quality tools, ISO and IPC standards, and process validation.
- Experience coordinating and executing IQ/OQ/PQ process validation.
- Ability to utilize software for data analysis and reporting.
- Strong understanding of product and manufacturing processes.
- Knowledge of the business unit and its impact on customer satisfaction, product quality, delivery, and profitability.
- Expertise in quality tools (FMEA, PMP, SPC, 8D) and methodologies (Six Sigma, Lean Kaizen).
- Excellent communication skills for interacting with internal and external stakeholders.
- A preferable candidate is from the medical device manufacturing industry