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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 multi-site 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 third-party compliance audits.
What you need:
· Bachelor’s 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, problem-solving, and data-driven decision-making skills.
· Excellent planning, organization, and multi-tasking abilities.
· Strong communication skills with the ability to communicate effectively across all levels of the organization.