SR. COMPUTER SYSTEMS VALIDATION SPECIALIST
Company: KARL STORZ ENDOSCOPY
Location: Santa Barbara
Posted on: September 26, 2024
Job Description:
KARL STORZ is currently seeking an experienced Senior Computer
Systems Validation (CSV) Specialist to lead our global non-device
software validation process, ensuring compliance with regulatory
requirements and industry standards. Collaborate with
cross-functional teams, manage validation projects, and provide
technical expertise to ensure timely delivery of software system
solutions. Key Responsibilities:
- Manage and support all U.S. non-device software validation
activities for manufacturing and distribution sites
- Develop and implement CSV workflows, analyze system solutions
and support validation protocols, reports and other applicable
documentation
- Assure validation activities are conducted in a compliant and
timely manner
- Evaluate and audit software documentation and processes
- Provide guidance and recommendations to software users on
qualification/validation requirements
- Collaborate with stakeholders to validate system solutions
- Develop and manage validation documentation and databases
- Lead risk assessments and analyze validation test data
- Identify and mitigate software validation gaps
- Remains current on new and emerging best practices for software
validation Requirements:
- 7+ years of CSV experience with at least 5 years experience in
a regulated industry (medical device, auto, aerospace manufacturing
QMS environment)
- Associate's degree in Applied Science (or relevant certificates
with proven experience)
- Proficiency in regulatory and quality regulations (ISO
13485:2016, FDA 21 CFR 820, FDA 21 CFR Part 11)
- Subject matter expert of software validation industry standards
and current regulatory environment to provide technical guidance
and expertise related to regulatory compliance.
- Experience in managing validation projects.
- Able to prepare written reports and give presentations to all
levels of the organization
- Strong technical writing and computer skills
- Excellent communication, leadership, and problem-solving
abilities
- Abiity to travel up to 10% Physical Requirements:
- Ability to lift up to 20 lbs on occasion
- Ability to stand and walk for periods of time when
participating in audits Preferred Qualifications:
- 8+ years of CSV experience with progressive responsibility
managing CSV activities
- Bachelor's degree in software engineering, computer science,
IT, or data science
- Experience in validation activities in medical device industry,
specifically meeting FDA 21 CFR Part 11 compliance
- Excellent technical skills and project management abilities Who
we are: KARL STORZ is an independent, family-owned company
headquartered in Germany's renowned MedTech manufacturing
region.For 80 years, we've pioneered the most groundbreaking
innovations in endoscopic surgery, video imaging, and operating
room integration to benefit patients and healthcare providers
alike. With more than 9,000 associates worldwide and 2,600 in the
US, we pride ourselves on harnessing cutting-edge technology,
precise workmanship, and unrivaled customer support to help
healthcare facilities succeed. With onsite locations and field
opportunities across the country, we attract a diverse and talented
staff. It's not just about the tools we create-it's about the lives
we change, together. #LI-CW1
Keywords: KARL STORZ ENDOSCOPY, Santa Barbara , SR. COMPUTER SYSTEMS VALIDATION SPECIALIST, IT / Software / Systems , Santa Barbara, California
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