Sr. Computer Systems Validation Specialist

2 days ago

Goleta, United States Disability Solutions Full time
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. This role will be responsible for collaborating with cross-functional teams, managing validation projects, and providing 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

MA Applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Eligible Employee Benefits
  • Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too
  • 3 weeks vacation, 11 holidays plus paid sick time
  • Up to 8 weeks of 100% paid company parental leave; includes maternal/ paternal leave, adoption, and fostering of a child.
  • 401(k) retirement savings plan providing a match of 60% of the employee's first 6% contribution (up to IRS limits)
  • Section 125 Flexible Spending Accounts
  • Life, STD, LTD & LTC Insurance
  • We prepay your tuition up to $5,250 per year - Tuition pre-imbursement
  • Fitness reimbursement of up to $200 annually
  • And much more

KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employees must comply will all applicable KARL STORZ policies and procedures.

Credentialing requirements at KARL STORZ

KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.

Pay Transparency

The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member's base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.

Equal Employment Opportunity & Reasonable Accommodation Statement

KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at taoperations@karlstorz.com.

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