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Quality Engineer - Medical Device

Quality Engineer - Medical Device

TALENTMATE

0 years

0 Lacs

gurgaon haryana india

Posted:2 weeks ago| Platform:

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Skills Required

risk management design support engineering development usability reliability verification test doe fmea compliance testing regulations analysis assessment software sigma controls metrics consulting portal manufacturing azure data research payments security

Work Mode

On-site

Job Type

Full Time

Job Description

"QMS Knowledge of Regulatory standards CFR820 , ISO 13485 & 14971, 60601 Hands on experience on Risk Management. Good understanding of Post Market Survey and complaint handling. Design plan Medical Process DQC Deviation and CAPA preferred.""

Be a part of core project team and support the quality engineering across the entire development cycle
Lead product risk management, usability, reliability and design validation efforts for new product development and design change projects.
Lead the development and implementation of design verification and validation plans with project design lead.
Lead the development of Critical to Quality (CTQs), design input and output documents.
Lead the fixture qualification and test method validation.
Participate and implement tools like Design of Experiments (DOE’s), FMEA sessions, Risk Management and ensure compliance to CTQ’s and safety requirements.
Manage electronic document control and version control on all project related documents.
Ensure adherence to the quality systems and design assurance SOPs.
Lead usability, reliability, testing, verification and validation testing – internal and local vendors.
Provide statistical testing and reliability plans.
Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution.
Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable).
Co-Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).
Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed quality."

Job DetailsRole Level: Entry-Level Work Type: Full-Time Country: India City: Gurgaon ,Haryana Company Website: https://www.infosys.com Job Function: Quality Assurance & Control Company Industry/Sector: IT Services and IT ConsultingWhat We Offer

About The Company

Searching, interviewing and hiring are all part of the professional life. The TALENTMATE Portal idea is to fill and help professionals doing one of them by bringing together the requisites under One Roof. Whether you're hunting for your Next Job Opportunity or Looking for Potential Employers, we're here to lend you a Helping Hand.ReportSimilar JobsAccount ManagerTalentmateConsultant - Business Consulting Manufacturing Supply Chain MngmntTalentmateAI Senior Solutions ConsultantTalentmateSenior ConsultantTalentmatePower BI And Azure Data Factory Consultant Mid-LevelTalentmateInsurance ConsultantTalentmateDisclaimer: talentmate.com is only a platform to bring jobseekers & employers together. Applicants are advised to research the bonafides of the prospective employer independently. We do NOT endorse any requests for money payments and strictly advice against sharing personal or bank related information. We also recommend you visit Security Advice for more information. If you suspect any fraud or malpractice, email us at abuse@talentmate.com.

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Quality Engineer - Medical Device