Senior Staff, Advanced Quality Engineer, R&D, Neurosurgical
- Cork
- Permanent
- Full-time
- Work closely with operations and the business functions to assess, provide oversight and direction on quality performance of product and processes. (SGS).
- Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues. (DD).
- Mentors, provides oversight and approval of NC/CAPA, activist and high-level expert in problem-solving and root-causing activities.
- Leads quality initiatives or projects.
- Recognized process owner, with expertise across multiple quality areas.
- Provides input into local, global, and corporate processes, represents function on review boards and teams.
- Provides input, assessment, and justification at expert level for concessions, change management, and quality issues. (SGS).
- Review and approval of change management activities, challenges effectiveness and drives strong review.
- Interpret KPI trends, drive continuous improvement process.
- Advocate of Human Factor practices, proficiency in the science of identification of mitigation.
- Engage in and may lead internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. May manage audit logistics and/or preparation.
- Aids in the development of validation strategies for existing products. (SGS).
- Supports/leads manufacturing transfers to other plants/facilities, leading quality activities. (SGS).
- Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes.
- Coach and mentor others in quality topics and activities.
- BS in a science, engineering or related discipline (Level 8).
- MS, CQE, or CRE desired
- Six Sigma Green or Black belt desired
- Minimum of 6 years experience preferred.