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's 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 5-7 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's 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
