AddressHeidelco Medicore Pvt Ltd. (POCT Group Company)
A Leading Brand in Critical Care Equipements segment (Electronic Medical Devices) like: Ventilators, Anesthesia Workstation, ECG Machine, Patient Monitor, and Oxygen Concentrator.
Are you a dynamic and results-driven Quality Assurance profile with a passion for building and enhancing processes with the optimum level of Quality and product validation for Critical Care Equipements segment (Electronic Medical Devices) We're looking for a talented individual to join our team as a Quality Assurance Manager.
Job Description
Preparation & implementation of Quality Management Systems.
Timely equipment maintenance and calibration from NABL accredited lab.
Controlling and managing document processes by reviewing files, records and ensure compliance with policies and procedures.
Determine the human resources and material resources required and manage them to meet production/ quality targets.
QAP (Quality Assurance Procedure/plan) preparation in consultations with the client.
Monitor and review the performance of staff and organize necessary trainings for improvements.
To Maintain high quality standards, adhering to regulatory and ISO requirements (ISO9001:2015, ISO17025, ISO14001 & ISO45001).
Reporting to upper management on quality standard issues & also engaging with customers and gathering product feedback.
Prepare the Quality Manual, Procedures, Work Instruction and Formats/Records for the continuous compliance of ISO 17025:2017.
Tie up with the NABL auditors for the audits and NABL accreditation.
Conduct the MRM (Management review meetings) & preparation of MOM (Minutes of meetings).
Carry out internal audit as per the ISO17025:2017 and close the NCs within timelines.
Carry out the tests as per the Standards (EU CE MDD 93/22/EEC, MDR 2017/745 ISO 13485, MIL810G)
Prepare stage wise work instructions, assembling process, quality check points, Dos & Don'ts.
Supervising staff and monitoring production and quality standards.
Examining the quality of raw materials that are used in production.
Evaluating the final output of products to determine their quality & rejecting products that fail quality standards.
Mandatory Requirements
Proven experience of Quality Assurance in Medical Device Manufacturing with a focus on in detail Electronic Medical Instruments
Strong project management skills and ability to multitask effectively.
Excellent communication and creative thinking skills. Familiarity with Electronic Medical Instruments and technologies.
NOTE: ONLY SIMILAR EXPERIENCE CANDIDATES ARE ELIGIBLE, AS PER THE PRODUCT LINE MENTIONED IN ABOVE JOB POST.
Skills: project management,eu ce mdd 93/22/eec,iso requirements,staff performance review,Quality Assurance,mil810g,nabl accreditation,internal audit,communication skills,raw material evaluation,document processes,mdr 2017/745 iso 13485,equipment maintenance,quality management systems
Skills: Internal Audit, Communication Skills, Project Management, Equipment Maintenance, Quality Assurance
Experience: 5.00-7.00 Years
