Aurigene Pharmaceutical Services
2 weeks ago
a key member of our engineering organization, you will play a crucial role in driving and maintaining a robust Quality Management System (QMS).
You will be responsible for implementing and improving quality processes, ensuring compliance with industry standards (e.g., ISO 9001), and driving continuous improvement across the engineering organization.
Key Responsibilities :
QMS Implementation & Maintenance :
- Lead the implementation and maintenance of the Engineering QMS, including ISO 9001 :2015 or other relevant standards.
- Develop, review, and maintain QMS documentation, such as procedures, work instructions, quality plans, and risk assessments.
- Conduct internal audits and assessments to ensure compliance with QMS requirements and identify areas for improvement.
- Participate in management reviews and contribute to the continuous improvement of the QMS.
Process Improvement & Optimization :
- Analyze engineering processes (e.g., software development, testing, release management) to identify areas for improvement in terms of quality, efficiency, and effectiveness.
- Develop and implement process improvement initiatives, such as Lean Six Sigma, to streamline workflows and reduce defects.
- Participate in root cause analysis and corrective/preventive action (CAPA) activities.
Risk Management :
- Conduct risk assessments, identify potential quality risks, and develop and implement mitigation strategies.
- Monitor and track the effectiveness of risk mitigation plans.
Data Analysis & Reporting :
- Collect, analyze, and report on key quality metrics and KPIs (e.g., defect rates, cycle times, customer satisfaction).
- Prepare reports and presentations to communicate quality performance to management and stakeholders.
Stakeholder Management :
- Collaborate effectively with engineering teams, project managers, and other stakeholders to ensure QMS compliance and continuous improvement.
- Communicate QMS requirements and best practices to all relevant personnel.
Qualifications :
- Bachelor's degree in Engineering, Computer Science, or a related field.
- experience in Quality Assurance or a similar role within an engineering environment.
- In-depth knowledge and experience with ISO 9001 :2015 or other relevant quality management standards.
- Proven experience in implementing and maintaining QMS within an organization.
- Strong understanding of software development lifecycle (SDLC) methodologies (e.g., Agile, Scrum).
- Experience with risk management methodologies and tools.
- Excellent analytical and problem-solving skills with strong attention to detail.
- Excellent communication, interpersonal, and presentation skills.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Strong organizational and time management skills.
Preferred Qualifications :
- Experience with statistical process control (SPC) techniques.
- Experience with quality management software tools (e.g., Jira Align, Planview).
- Knowledge of Lean Six Sigma methodologies.
- Experience with data analysis and reporting tools.
- Relevant certifications (e.g., Certified Quality Engineer, Six Sigma Black Belt)
(ref:hirist.tech)-
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