Job description:

- Ensures 100 percent quality and regulatory compliance in accordance with documented procedures.

- Leads, acknowledges, develops, communicates & implements a strategy at site to ensure compliance.

- Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the manufacturing site.

- Supports continuous product and process improvement through detailed failure analysis for non-conformance, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).

- Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.

- Plans and executes of the audit activities necessary for monitoring the Quality Management system and plays a major role in all internal/external audits.

- Assists in completing the NCR (Non-Conformance Reporting) and PPC (Product and Process Change) activities.

- Conducts internal and external audits, MRMs, Gap Analysis.

- Ensures that Design and Development activities are conducted as per applicable standards.

- Assists in Risk Management Activities, facilitates the failure mode effects analysis and mitigation of risks.

- Performs a broad variety of tasks in support of product and process design as required.

- Manages rapidly changing situations and thrives in a dynamic startup environment.

Job Specifications :

Skills required :

Mandatory :

1. Minimum of 3 years experience in a regulated industry is preferred

2. Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.

3. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes

4. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.

5. Demonstrated collaboration, negotiation & conflict resolution skills

6. Excellent communication skills (written and oral)

7. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance

8. Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.

9. Experience performing internal audits and participating in external audits

10. Exceptional analytical, problem solving & root-cause analysis skills

11. Ability to multi-task & handle tasks with competing priorities effectively

12. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators

Qualification required : Minimum Bachelor's degree in Biomedical Engg or Master's degree in any domain of Life Sciences

Experience required :

1. A minimum of 2-4 years work experience

2. Minimum of 1 year experience working in Medical Devices

3. Ability to communicate effectively in English (both written and oral)

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