Quality Engineer FGO QMS Global Capability Centre
Quality Engineer FGO QMS Global Capability Centre
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Job Description
The Quality Engineer will support the oversight and assessment of changes to the quality management system overseeing and ensuring that changes to processes and procedures are compliant effective and pose no risk to the quality of the product or processes.
What you will do:
Execute & Participate in the Change Control review forums and in multisite forums
Facilitate and mentor teams through all stages of the change control process.
Reviews changes for sound rationale challenging justification correct approval and oversight and resulting status of change requests.
Product Manager within the system. This role has full administrative access in the systems. Responsibilities as part of this role include:
Setting up new projects moving & assessing objects within containers establishing groups within containers and troubleshooting issues in onePLM.
Interface and troubleshoot issues between the onePLM system and the various departments/project teams. Ensuring solutions are implemented in a compliant timely and fully traceable manner while ensuring business timelines and milestones are met.
Subject Matter Expert on all related procedures and process SME ensuring compliance to the relevant corporate procedures.
Support any training needs related to the change control process
Manage Change Control KPIs including reporting requirements provide detailed updates and information in support of quality & business review forums.
Coordinate in preparation participate and follow up to Stryker Internal Corporate and thirdparty compliance audits.
What you need:
Bachelors degree in a Science Engineering or related discipline preferred.
2 years in Quality/Regulatory Affairs environment with 1 year experience in a role exposed to Quality Management Systems.
Fluency in English essential.
Preferred Qualifications:
Experience in interacting with regulatory agencies (FDA MoH TUV etc. is a plus.
Ability to gain knowledge and understanding of US and International Medical Device Regulations.
Ability to gain knowledge of supporting Quality Systems (e.g. Audits Management review Quality Planning).
Strong analytical problemsolving and datadriven decisionmaking skills.
Excellent planning organization and multitasking abilities.
Strong communication skills with the ability to communicate effectively across all levels of the organization.
Travel Percentage: 10Required Experience:
Exec
Employment Type
Full-Time
