Quality Management Lead
4 days ago
**Job Summary:**
This role oversees quality management activities, ensuring product excellence throughout the entire lifecycle. The position demands expertise in regulatory compliance (ISO 13485, FDA), process validation, and continuous improvement methodologies.
**Key Responsibilities:**
Quality Leadership:
- Direct a team in resolving quality deviations and implementing timely corrective actions.
- Ensure adherence to ISO 13485 and applicable regulatory requirements (e.g., FDA).
- Oversee product quality 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 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 has experience in the medical device manufacturing industry.
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