Qms

4 days ago

Daman, India Aum Global Solutions Full time

Job Responsibilities:

- Developing, implementing and maintaining Quality Management Systems (QMS) that comply with relevant standards and regulations, such as ISO 9001, ISO 13485, and FDA requirements.
- Analyzing and evaluating the effectiveness of the QMS through internal audits, management review meetings, and corrective action management.
- Creating and maintaining documentation related to quality standards, policies, procedures, and instructions.
- Monitoring the product lifecycle from development to commercialization, ensuring that quality standards are met.
- Identifying and implementing process improvements that optimize the QMS, including the development of training materials for staff.
- Collaborating with cross-functional teams, such as R&D, engineering, and manufacturing, to ensure that quality requirements are met throughout the product development process.
- Conducting supplier evaluations, selecting and qualifying new suppliers, and managing supplier performance.
- Conducting risk assessments and developing risk management plans for products.
- Participating in regulatory audits and inspections, including preparation and follow-up activities.
- Communicating quality metrics and results to senior management and other stakeholders.

Job Requirements:

- B.Sc/M.Sc/ Btech/B.E./Diploma in Quality Management, Mechanical Engineering, Chemical Engineering, or a related field.
- 5-10 years of experience in Quality Management Systems, preferably in the medical device, pharmaceutical, or other regulated industry.
- Familiarity with QMS standards and regulations, such as ISO 9001, ISO 13485, and FDA requirements.
- Experience in internal audits, CAPA management, and risk management.
- Strong communication and interpersonal skills to effectively collaborate with cross-functional teams.
- Excellent problem-solving and decision-making skills.
- Ability to manage multiple projects and priorities simultaneously.
- Strong attention to detail and ability to maintain accurate and organized documentation.
- Experience with statistical analysis and tools for quality management.
- Familiarity with tools for quality management, such as Six Sigma, Lean, or Total Quality Management (TQM).

Pay: ₹400,000.00 - ₹600,000.00 per year

Schedule:

- Flexible shift

Ability to commute/relocate:

- Daman, Daman and Diu: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 5 years (preferred)

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