Quality Assurance Leader - Medical Devices, NPD & Compliance

Talent Elite Group; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Talent Elite Group is seeking a Quality Assurance Manager for a growing medical manufacturing client in Irvine, CA. This fully on-site role oversees QA for product development, regulatory compliance, and contract manufacturing.

You will lead a team, drive new product development, maintain ISO 13485 compliance, SaMD awareness, and implement robust quality systems. A Bachelor’s degree in engineering and 7+ years of QA leadership are required, with strong regulatory knowledge and collaboration with

Qualifications

• Bachelor’s degree in a related engineering discipline.
• Minimum seven (7) years of related quality assurance experience.
• Previous management and leadership experience.
• Advanced knowledge with development and test requirements with recognized standards (ISO 13485).
• Previous experience with New Product Development.
• Regulatory requirements for software applications (SaMD).
• Knowledge of software QA processes and QMS applications.

Responsibilities

• Ensures products meet customer requirements and complies with US and international regulations.
• Manages new product development and process improvement projects.
• Hires, manages, trains, develops, reviews, and sets goals for department and staff.
• Acts as coach and mentor for problem solving and process improvement.
• Oversees the quality system to support development and contract manufacturing of medical products.
• Manages staff adherence to company policies and procedures.
• Oversees implementation of new products against market and technical standards.
• Evaluates manufacturing processes to ensure quality and timely project flow.
• Implements inspection, testing, and evaluation methods for products and production equipment.
• Develops quality assurance strategies including new European standards (MDSAP) where applicable.
• Prepares and presents performance and technical information to management.

Skills

Quality management

Regulatory knowledge

Leadership

Software QA

ISO 13485

Education

Bachelor's degree in engineering

Job description

Talent Elite Group is seeking a Quality Assurance Manager for a growing medical manufacturing client in Irvine, CA. This fully on-site role oversees QA for product development, regulatory compliance, and contract manufacturing.

You will lead a team, drive new product development, maintain ISO 13485 compliance, SaMD awareness, and implement robust quality systems. A Bachelor’s degree in engineering and 7+ years of QA leadership are required, with strong regulatory knowledge and collaboration with