**Careers that Change Lives\**
- A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. Join us as a valued team member at our Costa Rica, Alajuela, Manufacturing site. We look for accountable leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers.
- Bring your talents to an industry leader in medical technology and healthcare solutions - we're a market leader and growing every day. You can be proud to be a part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We encourage and support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.
**A Day in the Life**
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The Senior Quality Engineer Systems Supervisor will oversee the quality systems team, ensuring compliance with regulatory requirements and internal standards. This role involves leading quality improvement initiatives, managing quality system processes, and supervising a team of quality engineers and technicians.
Responsibilities may include the following and other duties may be assigned.
- Provides oversight for the development and maintenance of quality programs, systems, 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.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
- Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
- Manage CAPA (Corrective and Preventive Action) processes, root cause analysis, and continuous improvement initiatives.
- Supervise and mentor a team of quality engineers and technicians.
- Lead quality system initiatives to improve product and process quality.
- Coordinate with cross-functional teams to ensure quality standards are met.
- Co-ordinates legal requests in support of government investigations or litigations.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Analyze quality data and metrics to identify trends and areas for improvement.
- Prepare and present quality performance reports to senior management.
- Utilize statistical tools and methodologies to support quality improvement efforts.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
- Promote a culture of quality and continuous improvement within the organization.
**Must Have: Minimum Requirements**
- Bachelor's degree in Engineering, Quality Assurance, or a related field.
- Minimum of 5+ years of experience in quality engineering within the medical device manufacturing industry or related, or an advanced degree with a minimum of 2+ year of relevant experience.
- Strong knowledge of ISO 13485, FDA regulations, and other relevant quality standards.
- Advanced English (Bilingual English - Spanish Communication and Business Proficiency, and excellent written and verbal communication).
- Excellent leadership, communication, and interpersonal skills.
- Proficiency in statistical analysis tools and quality management software.
- Certification in Quality Engineering (CQE), Quality Management (CQM), or related certifications is preferred.
- Experience in manufacturing or quality engineering of medical devices.
**Nice to Have**
- Good knowledge of ISO 13485.
- ISO 9001 Internal Auditor / Lead Auditor Cerification.
- ISO 13485 Internal Auditor / Lead Auditor Cerification.Lean Six Sigma Green Belt or Black Belt.
- Experience in leading a team and managing cross-functional teams like production, Quality or other, etc.
- Strong coaching and people leadership skills.
- Strong analytical, planning, Quality, regulation, and organizational skills.
- Knowledge of Six Sigma Methodology and Lean Manufacturing.
- Proficiency in Project Management.
- Audit - Quality and Compliance Experience.
- Corrective and Preventative Action (CAPA).
- Quality Management System Experience.
- Quality System Regulation Experience.
- Strong decision-making ability.
- Good interpersonal and influencing skills
**Why Join Us?**
- Be a part of a mission-driven co