Quality Engineer - QMS

Job Description

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 Stryker&aposs 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 EU&aposs 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

Alongside its customers around the world, Stryker impacts more than 150 million patients annually.