Senior Director, Product Quality Assurance
BioTalent Ltd, San Diego, CA, United States
We are hiring a Director / Senior Director of Product Quality
to lead lifecycle quality strategy and process transformation initiatives across a complex regulated product portfolio. This role oversees Quality Engineering and Quality Control functions supporting inspection, sustaining activities, validation, and CAPA execution. This leader will drive enterprise product quality improvements, implement Six Sigma methodologies, and strengthen validation and CAPA maturity across the organization.
Responsibilities
Lead Quality Engineering and Quality Control organizations
Oversee incoming inspection, final QC inspection, and sustaining quality support
Drive process transformation initiatives across validation and CAPA systems
Support design changes and lifecycle product quality strategy
Implement Six Sigma tools to improve operational effectiveness
Partner with cross-functional stakeholders across Operations, R&D, and Regulatory
Strengthen inspection readiness and compliance posture
Mentor managers and develop technical quality leadership capability
Requirements
15–20+ years experience in regulated medical device or IVD environments
Certified Quality Engineer (CQE) required
Six Sigma Black Belt requiredDeep expertise in CAPA and process validation
Experience managing large technical teams (30-40+) in inspection or QC environments
Strong background supporting lifecycle product quality
Familiarity with GD&T and mechanical inspection preferred
IVD experience preferred (medical device acceptable)
Proven experience leading Quality through Change & Transformation
Work Environment
Primarily onsite leadership role (4X per week)
Compensation
Base salary $180-240k + bonus
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to lead lifecycle quality strategy and process transformation initiatives across a complex regulated product portfolio. This role oversees Quality Engineering and Quality Control functions supporting inspection, sustaining activities, validation, and CAPA execution. This leader will drive enterprise product quality improvements, implement Six Sigma methodologies, and strengthen validation and CAPA maturity across the organization.
Responsibilities
Lead Quality Engineering and Quality Control organizations
Oversee incoming inspection, final QC inspection, and sustaining quality support
Drive process transformation initiatives across validation and CAPA systems
Support design changes and lifecycle product quality strategy
Implement Six Sigma tools to improve operational effectiveness
Partner with cross-functional stakeholders across Operations, R&D, and Regulatory
Strengthen inspection readiness and compliance posture
Mentor managers and develop technical quality leadership capability
Requirements
15–20+ years experience in regulated medical device or IVD environments
Certified Quality Engineer (CQE) required
Six Sigma Black Belt requiredDeep expertise in CAPA and process validation
Experience managing large technical teams (30-40+) in inspection or QC environments
Strong background supporting lifecycle product quality
Familiarity with GD&T and mechanical inspection preferred
IVD experience preferred (medical device acceptable)
Proven experience leading Quality through Change & Transformation
Work Environment
Primarily onsite leadership role (4X per week)
Compensation
Base salary $180-240k + bonus
#J-18808-Ljbffr