Supplier Quality Engineer

4 weeks ago

Bengaluru, India Advanced Sterilization Products Full time

Position Summary

The Supplier Quality Engineer will maintain quality assurance standards which adhere to Quality System Requirements (21 CFR 820), ISO regulations (ISO 13485) and other applicable regulations to ensure products and services are provided to customer requirements. This position is responsible for the quality and regulatory compliance of products manufactured at Suppliers and External Manufacturers.


Candidates who have prior experience in (sampling, design of experiments, process capability analysis) as well as the capability to review manufacturing processes (Control plan, process control and quality control) will be given higher considerations.


Duties and Responsibilities

  • Will monitor quality performance of suppliers and external manufacturer’s and provide support in maintaining and reporting supplier quality metrics.
  • Will support in executing supplier change request activities and other routine supplier quality actions
  • Support in the investigation of manufacturing product quality and compliance issues with assistance from appropriate SMEs and senior team members(e.g., CAPA, non-conformances, audit observations) Will support teams to investigate quality issues (Failure investigations) to resolve complaints, non-conforming products and CAPA
  • Will provide support to maintain good documentation to support validation processes, specifications, manufacturing and test procedures.
  • Will participate and collaborate with Supply chain, R&D Engineering, Operations Engineering and other stakeholders to identify potential areas of process variability, address root causes and implement improvements.
  • Will be responsible for maintaining supplier information in purchasing system
  • Will participate and support in process improvement activities.
  • Responsible for communicating business related issues or opportunities to next management level
  • Performs other duties assigned as needed.


Qualifications

  • Bachelor’s Degree, Electrical Engineering (BSEE), Mechanical Engineering (BSME), Chemical Engineering (BSCE), BS Microbiology (BSc) or other related Engineering practices is required.
  • 2+ years of work experience (or equivalent) in the Medical Device industry, medical field or regulated environment, or in other applicable quality roles.
  • English communication skills required (read/ write).
  • Prior experience within an electro-mechanical or chemical environment as well as previous medical device experience is preferred.
  • Prior knowledge of medical device regulations such as 21 CFR 820 and ISO 13485 are preferred.
  • Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts.
  • Must have good organizational skills.
  • Prior experience using electronic QMS software and SAP preferred.
  • Experience with Qualification and Process validations and the use/application of statistical tools.


Office Address:

#16 Salarpuria Premia (Opp. Cessna Business Park)

Sarjapur Outer Ring Road (ORR)

Bangalore 560103

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