Medical equipment RA QA Engineer

2 days ago

Hyderabad, Telangana, India Althion Full time ₹ 6,00,000 - ₹ 12,00,000 per year

Job description

Althion is a Hyderabad based med-tech/water-tech company developing and manufacturing an exciting portfolio of medical devices and equipment. With initial R&D and manufacturing set-up funded by BIRAC, and solid traction in India for its line of kidney dialysis grade ultra-pure water products, Althion is now well positioned to expand to other markets. We are looking to strengthen our manufacturing processes and R&D program in our world-class facility.

QA Engineer

Keywords: QA, certifications , medical equipment R&D and manufacture, healthcare

Qualifications and Experience:

  • Education: BE (Mech)/ MTech (Mech) or similar
  • Experience: 3 to 8 years proven experience in similar role knowledge in the medical device/manufacturing domain is must
  • Excellent communication skills.
  • Ability to work independently and in a team environment.

Responsibilities


• Responsible for incoming inspection, in process inspection, final inspection, testing, trial run and PDIR.


• Implementation of ISO 13485, CDSCO, BIS, CE marking, IEC 60601, etc. Handle entire documentation requirement for all certifications.


• As an MR, Plan, conduct internal audits and to follow up for NC closures.


• Conduct trainings as and when required in consultation with other HODs to achieve quality standards.


• Liaison with external agencies (certification body, consultants) on matters pertaining to QMS and other certifications.


• Ensuring and facilitating supplier audit, tool audit, 5S audits conducted on-time.


• Identifying the inspected items/materials/products with Colour coding


• Responsible for documenting the inspection & testing records/reports.


• Responsible for getting approval for the deviations observed on products/materials/components etc.


• Responsible for maintaining calibration of measuring instruments/equipments.


• Responsible for Process achievement (KPI) in QA/QC Department.


• Contribution in machine trials & proving with R&R study, Cp & Cpk calculations.


• Problem solving with 8D methods.


• Knowledge about TQM, QMS, SPC/SQC ,7QC Tools, CAPA & inspection sampling methods etc.


• Lead or participate in quality-related projects, such as Kaizen activities and Poka yoke.

Attractive package with ESOPs and performance incentives

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