Metabyte Hiring for Validation Engineer – Medical Device Job at San Diego, CA Full Time

PREFERRED QUALIFICATIONS:
 Experience in validation of In Vitro Diagnostic Lab equipment (e.g., Real- Time
PCR System, Freezers, Refrigerators, Environmental Chambers, Incubators,
etc.), Thermal Validations and Computerized System Validation.
 Experience supporting ISO 13485 inspections and FDA inspections.
 Experience in a multi-site development environment.
 Experience in compliance management within a rapid-growth, dynamic
organization.
 Statistical or Lean Six Sigma background
 Familiarity with GAMP5 and FDA’s Computer Software Assurance initiatives
 Familiarity with Agile, Maximo and Viewlinc
COMPETENCIES:
 Good working knowledge of Excel and Microsoft Word software
 Working knowledge of quality techniques such as root cause analysis, 5 why’s,
and Ishikawa diagrams.
 Excellent problem solving and decision-making skills.
 Self-starting, detail oriented, and ability to focus on task at hand
 Initiative to work towards goals with minimal supervision
 Ability to work independently with multiple departments to resolve Validation
issues
 Must be able to work effectively in a fast paced, cross-functional team-oriented
environment
 Well-developed English written and verbal communication skills

Job Type: Full-time

Pay: $43.00 – $55.00 per hour

Benefits:

• Dental insurance
• Life insurance
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• San Diego, CA: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor’s (Preferred)

Experience:

• FDA, ISO 13485, ISO 14971 standards: 3 years (Preferred)
• Validation documentation, Validation protocol: 3 years (Preferred)
• FAT, DQ, engineering studies, IOQ, PQ, PV: 3 years (Preferred)
• gap analysis, risk management: 3 years (Preferred)
• In Vitro Diagnostic: 3 years (Preferred)

Work Location: One location