Quality Engineer- Medical Devices 58 views

Cyient is a global engineering and technology solutions company. As a Design, Build, and Maintain partner for leading organizations worldwide, we take solution ownership across the value chain to help clients focus on their core, innovate, and stay ahead of the curve. We leverage digital technologies, advanced analytics capabilities, and our domain knowledge and technical expertise, to solve complex business problems.

With over 15,000 employees globally, we partner with clients to operate as part of their extended team in ways that best suit their organization’s culture and requirements. Our industry focus includes aerospace and defence, healthcare, telecommunications, rail transportation, semiconductor, geospatial, industrial, and energy.

Job Description

Job Responsibilities:

– Provide support as Quality Engineer to ensure a high level of quality, following standards and regulations governing Medical industry.

– Understand and apply FDA CFR 820, ISO 13485, ISO 14971, Canadian, Japanese, Brazilian and European medical device regulations.

– Review design Practices & establish controls within business process

– Develop, review and approve procedures, technical/validation reports, change notices, risk assessments, and other related quality system documentation.

– Support investigations, CAPAs, process changes, quality plans and other Quality activities Lead or support internal and external quality system audits. Drive resolution of nonconformities.

– Drive continuous improvement of products and processes to reduce the cost of non-quality

– Be team-oriented, communicate suggestions and concerns, generate solutions, be flexible, and provide positive interaction and feedback with peers and internal departments.

– Effectively communicate with Customers to understand & appraise customer requirements

– Executing all tasks assigned by the team leader or manager diligently, on schedule, and to the highest standard

Job Requirements:

– 3-6 years of experience in the medical device or similar industry

– Strong verbal and written communication skills with both internal and external stakeholders

– Well-developed presentation and interpersonal skills

– The ability to influence and negotiate with all level of stakeholders

– The ability to prioritize multiple competing deliverables simultaneously

– External Quality System auditing experience.

– Computer Skills (MS office, statistical analysis software, PLM, ERP and QMS)

Qualifications:

Any Engineering degree (Mechanical Engineering preferred)

Skills & Experience Corrective and Preventive Action (CAPA), FDA Quality System Regulation, ISO 13485 Medical Devices, ISO 14971 Risk Management, Quality Management Systems (QMS), Statistical Data

Cyient is an Equal Opportunity Employer.

Cyient recruits, employs, trains, compensates, and promotes regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, veteran status, and other protected status as required by applicable law. We are proud to be a diverse and inclusive company where our people can focus their whole self on solving problems that matter.

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  • Total Jobs 479 Jobs
  • Location INDIA

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