Senior Quality Assurance Engineer

ZEISS Group

. Provide quality engineering support for manufacturing, purchasing, R&D, and product-sustaining activities.

Posted 10/30/2026full-timeDublin • California • United StatesSenior💰 $115,900 - $144,900 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance processes, including statistical methods, complaint investigations, and regulatory compliance within the medical device industry. Proven ability to lead quality improvement projects and effectively communicate across functions.

Highest-signal resume keywords

Quality AssuranceISO 13485FDA Quality Management System RegulationStatistical MethodsRoot-Cause Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Metrics DevelopmentProcess Capability AssessmentData AnalysisCAPARisk ManagementComplaint InvestigationQuality System ProcessesPerformance EvaluationRegulatory ReportingContinuous Improvement

Soft Skills

Strong Communication SkillsAdaptabilityDecision-MakingProject LeadershipCross-Functional Collaboration

Industry Keywords

Medical Device RequirementsRegulated IndustryManufacturing QualityProduct DevelopmentFailure AnalysisQuality Management SystemInternal AuditsExternal AuditsStakeholder CommunicationOphthalmic Products

About the role

Key responsibilities & impact

Provide quality engineering support for manufacturing, purchasing, R&D, and product-sustaining activities.
Serve as the Quality Assurance representative and subject-matter expert for assigned product families.
Develop and monitor product and process quality metrics, identify adverse trends, and lead appropriate improvement activities.
Apply statistical methods to product acceptance, process capability, sampling, data analysis, and performance evaluation.
Support product and process changes by assessing quality, regulatory, and risk-management impacts.
Lead or support complex quality investigations, root-cause analyses, corrective actions, and effectiveness evaluations.
Manage escalated product complaints and ensure that complaint records are complete, accurate, traceable, and properly maintained.
Assess complaint classification, potential regulatory reporting obligations, and the need for further investigation, risk evaluation, or quality action.
Coordinate complaint investigations, returned-product evaluations, regulatory reporting inputs, stakeholder communication, and timely closure.
Support the maintenance and continuous improvement of the Quality Management System.
Lead quality projects and provide technical guidance and training to other personnel.
Support regulatory inspections and internal or external audits, as required.

Requirements

What you’ll need

Bachelor’s degree in engineering, science, or a related technical discipline.
Minimum five years of relevant experience in quality assurance, product development, manufacturing quality, or failure analysis within a regulated industry.
Working knowledge of ISO 13485, FDA Quality Management System Regulation under 21 CFR Part 820, and applicable U.S. and EU medical device requirements.
Experience with complaint investigations, root-cause analysis, CAPA, risk management, and quality-system processes.
Proficiency in statistical methods, including sampling, process capability, confidence intervals, data-distribution assessment, and interpretation of quality data.
Demonstrated ability to lead multiple complex projects and work effectively across functions.
Strong written and verbal communication skills.
Ability to adapt and make sound decisions in a changing environment.
Experience with medical electronic, ophthalmic, optical, or similar regulated products is preferred.

Benefits

Comp & perks

Performance Bonus
Medical plans
Vision
Dental
401k Matching
Employee Assistance Programs
Vacation and sick pay
Retirement savings plan
Paid time off