Job Description

Required Skills & Experience:

• Bachelor's Degree in Engineering
• Minimum of 5 years of professional experience in Design Assurance
• At least 5 years of leadership experience
• Proven experience in the Medical Device industry

Preferred Skills & Experience:

• Advanced Degree in a related Engineering field
• Over 10 years of experience in the Medical Device industry
• Familiarity with Class III Implantable Medical Devices
• Experience with devices featuring embedded firmware
• Expertise in supporting Product Development, Sustaining, CAPA, and Post Market Surveillance

Job Description:

A leading client in the medical device sector is seeking an Associate Director of Design Quality Assurance to enhance their Quality organization. The ideal candidate will be a seasoned leader with robust knowledge in design controls and risk management, capable of driving compliance and optimizing processes for their team. This role involves overseeing 6 DQA Managers across multiple locations and reporting directly to the divisional Director of Quality. The position is audit-facing and demands a strong understanding of global regulatory standards and best practices to navigate the evolving landscape. This is a permanent role based in Valencia, CA, with a hybrid work arrangement requiring three days per week onsite.

Compensation :

$190K/yr to $205K/yr with 20% performance bonus

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

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