Medical equipment RA QA Engineer

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