Job description

Essential Functions:

• Understands and follows Prismatik’s Quality Manangement System per training.
• Understands and complies with rules and Company policies.
• Manages the internal audit lifecycle including but not limited to planning, generating the audit schedule, execution, reporting, managing response, and follow-up on commitments/CAPA.
• Conducts internal audits and participates in third party audits.
• Reviews and monitors documentation, as assigned, to ensure compliance with relevant standards, regulations, and guidance documents.
• Coordinates, liaises, and participates with internal teams to provide guidance on manufacturing processes or quality systems compliance.
• Stays abreast on relevant domestic and international standards and regulations in order to monitor and ensure conformance.
• Analyzes all elements of the Quality System and judges their degree of adherence to the criteria for management and control processes.
• Collects and analyzes data to evaluate department goals and objectives for the internal audit process.
• Performs verification and effectiveness check of the action items implemented by process owner.
• Maintains the Internal Audit database.
• Participates in supplier audit as part of critical supplier selection and evaluation.
• Interprets recommendations, observations, and findings from the result of the audit to ensure that corrective actions are appropriate and effective.
• Presents and distributes internal audit reports including action items from internal audit results.
• Participates in improvement projects for the Quality System, as needed.
• Performs other related duties and projects as business needs require at direction of management.

Education and Experience:

• Bachelor’s degree in related field or equivalent experience.
• Minimum of three (3) years of experience in quality systems within the medical device industry.
• Minimum four (4) years experience performing GMP/ISO internal audits.
• Training in Quality Systems including relevant Regulations and Standards.
• Previous experience developing and adhering to Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Standard Operating Procedurs (SOPs).
• Quality assurance experience in a manufacturing environment is a plus.
• Previous experience in root cause analysis and corrective and preventive action methods.
• Previous technical writing experience a plus.
• ASQ Certified Quality Auditor, ASQ Certified Biomedical Auditor, ASQ Certified Medical Device Auditor OR IRCA Certification preferred.

Job Type: Full-time

Pay: $60,807.44 - $138,959.87 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Irvine, CA 92612: Reliably commute or planning to relocate before starting work (Required)

Experience:

• quality systems within medical device: 3 years (Required)

Work Location: One location

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