Aurigene Pharmaceutical Services - Senior Engineer - QMS (4-10 yrs)

Job Description :

We are seeking a highly motivated and experienced Senior Engineer - QMS to join our growing Quality Assurance team. As 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)