RedBrick Staffing
This range is provided by RedBrick Staffing. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $140,000.00/yr - $170,000.00/yr
Direct message the job poster from RedBrick Staffing.
Responsibilities
Develop and execute quality strategies that align with product development, regulatory requirements, and business objectives.
Build, mentor, and lead a high-performing quality team, managing recruitment, onboarding, performance, and professional growth.
Act as Subject Matter Expert for quality systems, risk management, and design quality planning.
Lead hazard analyses, FMEA, benefit-risk assessments, and risk governance processes per ISO 14971.
Drive cross-functional collaboration with R&D, Manufacturing, Regulatory, and Service teams to ensure alignment of quality goals.
Oversee sustaining quality engineering projects, validations, product transfers, change controls, and calibrations.
Chair meetings to resolve quality issues, ensure accountability for CAPAs, and maintain audit readiness.
Monitor and analyze quality metrics, identifying trends and implementing proactive improvements.
Provide strategic input on evolving regulatory requirements (FDA, ISO, EU MDR, and international standards).
Manage departmental budgets, resources, and efficiency initiatives to support organizational growth.
Support business development through quality due diligence and integration activities.
Job Requirements
8+ years of experience in medical device quality, including direct management experience.
Strong knowledge of global regulatory requirements (ISO 13485, FDA QSR, EU MDR, and international standards).
Experience with complaint handling, adverse event reporting, CAPA, and corrective action processes.
Demonstrated leadership with proven ability to manage teams, set strategy, and deliver results.
Strong technical knowledge of medical devices and design controls.
Skilled in process improvement, trending/analysis reporting, and project management.
Excellent communication, collaboration, and team-building skills.
Seniority level
Director
Employment type
Full-time
Job function
Quality Assurance and Project Management
Industries: Biotechnology Research, Medical Equipment Manufacturing, and Hospitals and Health Care
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Base pay range $140,000.00/yr - $170,000.00/yr
Direct message the job poster from RedBrick Staffing.
Responsibilities
Develop and execute quality strategies that align with product development, regulatory requirements, and business objectives.
Build, mentor, and lead a high-performing quality team, managing recruitment, onboarding, performance, and professional growth.
Act as Subject Matter Expert for quality systems, risk management, and design quality planning.
Lead hazard analyses, FMEA, benefit-risk assessments, and risk governance processes per ISO 14971.
Drive cross-functional collaboration with R&D, Manufacturing, Regulatory, and Service teams to ensure alignment of quality goals.
Oversee sustaining quality engineering projects, validations, product transfers, change controls, and calibrations.
Chair meetings to resolve quality issues, ensure accountability for CAPAs, and maintain audit readiness.
Monitor and analyze quality metrics, identifying trends and implementing proactive improvements.
Provide strategic input on evolving regulatory requirements (FDA, ISO, EU MDR, and international standards).
Manage departmental budgets, resources, and efficiency initiatives to support organizational growth.
Support business development through quality due diligence and integration activities.
Job Requirements
8+ years of experience in medical device quality, including direct management experience.
Strong knowledge of global regulatory requirements (ISO 13485, FDA QSR, EU MDR, and international standards).
Experience with complaint handling, adverse event reporting, CAPA, and corrective action processes.
Demonstrated leadership with proven ability to manage teams, set strategy, and deliver results.
Strong technical knowledge of medical devices and design controls.
Skilled in process improvement, trending/analysis reporting, and project management.
Excellent communication, collaboration, and team-building skills.
Seniority level
Director
Employment type
Full-time
Job function
Quality Assurance and Project Management
Industries: Biotechnology Research, Medical Equipment Manufacturing, and Hospitals and Health Care
Referrals increase your chances of interviewing at RedBrick Staffing by 2x.
Get notified about new Director of Quality Assurance jobs in Orange County, CA.
#J-18808-Ljbffr