layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Quality Systems Engineer III at Boston Scientific

Global quality process and compliance ownership
Execute assigned process ownership responsibilities within a global governance framework while collaborating with global process stewards who provide compliance oversight.
Support standardization efforts and maintain audit readiness in accordance with applicable regulations and standards, including ISO 13485, 21 CFR Part 820 and EU MDR.
Participate in process monitoring, documentation updates, regulatory implementation activities and issue resolution to maintain a permanent state of compliance.
Digital quality systems and IT partnership
Serve as a quality systems subject matter expert and business partner for digital platforms supporting document and records control processes.
Collaborate with IT and cross-functional stakeholders to support system configuration, enhancements, issue resolution and lifecycle management activities.
Partner with IT to translate business and regulatory requirements into technical solutions, validation activities and testing strategies.
Support root cause investigations, incident management and timely resolution of system-related issues to minimize business disruption.
Continuous improvement and operational excellence
Support continuous improvement initiatives using structured methodologies, including VIP, to drive efficiency, scalability and operational excellence.
Identify, analyze and resolve quality system issues using systematic problem-solving methodologies, considering common practice or procedures.
Drive process enhancements that strengthen quality culture and improve overall system effectiveness.
Quality events, CAPA and risk management
Serve as an owner or contributor for nonconformance, exception and CAPA activities.
Support root cause analysis, corrective and preventive action planning, implementation and effectiveness verification.
Contribute to risk management activities and systemic issue resolution efforts.
Project leadership and global collaboration
Support global quality system projects, including process implementations, business transfers and acquisition integrations.
Contribute to the global quality systems roadmap and support alignment with organizational commitments and priorities.
Participate actively in Communities of Practice activities to promote standardization and adoption of best practices.
Audit and regulatory support
Support external audits and regulatory inspections through preparation, execution, back-room support and follow-up activities.
Develop training materials, audit support documentation and related compliance resources.
Leadership, mentorship and training
Guide and support Quality Systems Engineers while contributing to team capability development.
Deliver training on quality system processes, digital tools and applicable regulatory requirements.
Support broader departmental and Quality Systems initiatives as business needs require.

Quality Systems Engineer III

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