Quality Assurance Engineer

· The Quality Leader is responsible for providing manufacturing support in accordance with documented procedures and practices.

· This is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established QA fundamental practices that are utilized in the local business.

· The role involves hands-on work in the areas of design, design transfer, manufacturing, distribution, and service.

· Ensures process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of simple yet detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts.

· Bachelor’s Degree in an engineering or technical discipline (or non-technical degree with 2 years of experience in manufacturing, engineering or quality assurance experience in addition to any other experience requirements).

· 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.

· 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.

Kind Regards,

Pranil Gavade

732-844-8731

Integrated Resources, Inc.