Supplier Quality Engineer@USA
Saraca Solutions – Delhi, Delhi
We are searching for passionate quality engineer to join our customer as they strengthen their product portfolio, expand our services and solutions, and bring game changing technology to market. This team member will be responsible for working collaboratively with a team of cross-functional engineers. Weâ€™re looking for the candidate to have the following qualities:
- Curious, smart, and creative
- Good judgment and decision making skills
- Takes Ownership and Excellent communicator
- Responsible for auditing Supplier Controls processes, provide recommendations for continuous improvements and remediate open audit findings or observations.
- Responsible to collaborate across functional areas (R&D, Manufacturing, Procurement, etc.) to provide support for FMEA development, establishing Critical to Quality (CTQ) characteristics as well as communicate key characteristics of components to suppliers.
- Audit processes to ensure proper execution, CGMP and record creation
- Interact in corporate systems to ensure appropriate supplier controls.
- Develop recommendation to ensure compliance to 21 CFR 820 and ISO 13485
- Communicate with suppliers to obtain necessary records where appropriate (FAI, Control Plans, CoC, etc.)
- Confirm that processes affecting CTQs are in control
- BS or MS degree in Mechanical or Electrical Engineering with min 6 years in Medical Device Industry
Required Background & Capabilities:
- High level knowledge of the 21 CFR 820, ISO 13485 and ISO 14971, questioning attitude, able to prioritize and execute tasks in a dynamic environment.
- Expert working knowledge of standards and regulations applicable to supplier controls affecting a medical device
- Strong working knowledge of quality assurance principles and practices, industry and international safety standards
- More than 5-years’ experience in medical device or pharma environment
- Excellent communication (verbal & written) skills and Practices analytical problem solving skills
- Working knowledge of various software packages including Microsoft (Excel, Word, Project, and SharePoint) and SAP applications is desirable.
- Knowledge of implementing testing frameworks
- Highly organized with efficient use of time
- Ability to facilitate collaboration with cross-functional groups development in a team environment