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88 SGTC India Jobs
Quality Engineer - QMS
SGTC India
posted 4hr ago
Job Role Insights
Key skills for the job
Job Description
Work Flexibility: Hybrid
What you will do:
- Supports the Quality Management Systems compliance with the appropriate internal & external regulatory requirements, (including but not limited to FGO EU, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements)
- Contribute to developing optimum future state of QMS for business needs, aligned with Corporate, Divisional & GQO QMS requirements.
- Assess & Quantify requirements for support of QMS to optimum structure under which the service required will be provided.
- Drive GMP and GDP practices within Quality .
- Identify and implement improvement opportunities to increase the efficiency and effectiveness of the Quality Management Systems.
- Develop & deliver training/compliance for QMS group.
- Contribute to the development, maintenance and improvements of the policies, procedures, processes and systems.
- Implement best in class QMS practices and benchmark against industry leads and regulatory requirements.
- Ensure QMS reflects actual activities and business needs, and supports NPI requirements
- In a project environment, contribute to the development and/or modification of Strykers regional/local Quality Management Systems.
- Proficiently take part in information systems discussions as required. Thinks about QMS from an IT perspective, including proficient contributions to SRS/URS activity.
- Supports the business during audits to discuss system functionality.
What you need:
Required:
- B. Tech (Electronics / Electrical / Mechanical) with 2+ years of experience in Supplier quality.
- Knowledge of ISO 13485, FDA, EUMDR and regional medical device regulatory requirements.
- Ability to effectively communicate information to team members, leaders, management, and suppliers.
- Experience supporting third-party inspection (FDA, Notified Body etc. ) within the medical device industry.
- Understanding of Quality Systems & web-based interactions.
- Strong interpersonal skills to work with cross-functional teams (engineering, R&D, manufacturing, regulatory affairs).
- Proficiency in executing and leading projects, understands project stages.
- Proficient in improvement methods and processes.
Preferred:
- Understanding of Medical Device Regulatory Compliance (ISO 13485, CFR 820, or comparable standard / regulation) and EUs Medical Device Directive.
- Excellent communication and influencing skills, with the ability to manage multiple tasks and represent the Quality function across teams
- ISO 13485 Lead Auditor certification or equivalent
Employment Type: Full Time, Permanent
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