Validation Services Lead for IT/OT Projects
hace 4 días
Award-winning Medtronic is a global healthcare technology leader, and we are seeking an experienced Validation Services Lead to join our team in Costa Rica. As a key member of the Operations Innovation department, you will lead validation services required for the successful delivery of IT / OT projects. The chosen candidate will have the opportunity to contribute to global programs within the IT Ops & Innovation Portfolio, providing a great opportunity to learn and develop new skills.
The salary for this position is estimated at $120,000 per year, based on industry standards and location. We offer a competitive compensation package, including flexible benefits and opportunities for career growth and development.
Key Responsibilities:
- Lead validation services required for the successful delivery of IT / OT projects
- Develop and implement effective validation strategies and processes
- Collaborate with cross-functional teams, including IT, Ops & Innovation, QA, and Mfg. SMEs
- Ensure compliance with regulatory requirements, such as ISO13485, CFR 21 Part 11, and SOX (if applicable)
- Author project quality masterplans (PQMPs), validation plans (VPLs), and other key validation documentation
Required Skills and Qualifications:
- Bachelor's degree in engineering, Computer Science, or applicable technical degree
- Minimum of seven (7) years validation or quality related discipline experience in either life science, med tech, or pharmaceutical environment
- Experience with regulatory requirements and industry standards for pharmaceutical and/or medical device manufacture, such as 21 CFR Part 11, GAMP5, ISO, electronic records retention, configuration items list, FDA, and ICH guidance documents
- Demonstrated leadership and project management skills, including two-way communication skills, interpersonal and team building skills, achievement of project timelines, and customer requirements
About Medtronic:
We are a company that leads global healthcare technology and boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. We are engineers at heart—putting ambitious ideas to work to generate real solutions for real people.
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