Sr Quality Engineer - Quality Management Systems
Sr Quality Engineer - Quality Management Systems
Posted on :
06-04-2025
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1 Vacancy
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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 57 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 thirdparty inspection (FDA Notified Body etc. within the medical device industry.
- Understanding of Quality Systems & webbased interactions.
- Strong interpersonal skills to work with crossfunctional 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
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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