Medtronic
QualitySystemsSpecialist
“Quality Systems Specialist at Medtronic. Skills: Quality Management System (QMS) support and strengthening, Compliance with internal policies and applicable regulatory and governmental requirements, Process management, Cross-functional coordination, Vendor/stakeholder management, Operational metrics, Resource planning, Continuous improvement. Supporting and strengthening Medtronic’s Quality Management System (QMS) to ensure compliance with internal policies and applicable regulatory and governme”
What You'll Achieve.
Ensure compliance with internal policies and applicable regulatory and governmental requirements; Meet global quality and compliance expectations
What They're Looking For.
Must Have
Bachelor’s Degree in Engineering, Science, Quality, or a related discipline, Minimum of two years of relevant quality, regulatory, or compliance experience, Practical working knowledge of quality systems and quality assurance principles, Familiarity with regulatory and industry standards applicable to medical devices (e. g. , ISO 13485, MDSAP, or equivalent), Experience supporting audits and inspections, including preparation and response activities, Ability to interpret regulations, policies, and procedures and translate them into actionable guidance for stakeholders, documentation and report-writing skills, including experience with CAPA or similar quality tools, Ability to work independently with general supervision on moderately complex assignments, Effective communication skills, with the ability to collaborate across functions and share information clearly and professionally, Experience working in a regulated medical device or healthcare manufacturing environment, Exposure to global or regional quality systems, Experience supporting continuous improvement or process optimization initiatives
What You'll Do.
Supporting and strengthening Medtronic’s Quality Management System (QMS) to ensure compliance with internal policies and applicable regulatory and governmental requirements
Partnering closely with site and regional stakeholders to oversee quality processes
Supporting audits and inspections
Driving continuous improvement initiatives
Applying practical quality and regulatory knowledge to maintain effective quality programs
Enabling best practice sharing and global alignment across the organization
Oversight for the development and maintenance of quality programs
processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines
Providing expertise and guidance in interpreting policies
regulatory and/or governmental regulations
and internal regulations to assure compliance
Working directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations
Leading audit and inspection preparation
resolution of audit and inspection findings and liaising with auditing groups and inspectors through all stages of the audits
Preparing reports and/or necessary documentation (ex Corrective and Preventative Actions) and providing to applicable stakeholders
both internal and external
Co-ordinating legal requests in support of government investigations or litigations
Ensuring the quality assurance programs and policies are maintained and modified regularly
Facilitating uniform standards worldwide and enabling best practice sharing
thereby fostering the achievement of company's mission globally
How You'll Work.
Team & Collaboration
Partners closely with site and regional stakeholders; Collaborate across functions
Communication Scope
Effective communication skills; Ability to share information clearly and professionally
Process & Methodology
Moderately complex projects
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