Quality Assurance Manager

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

Our growing medical manufacturing client is seeking a Quality Assurance Manager to join their team. This role will be fully on-site out of their Irvine office.

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 set goals for department and staff.
• Acts as both coach and mentor to team members in areas of problem solving, decision-making, and process improvement.
• Addresses all employee relations matters in a timely manner in coordination with Human Resources.
• Manages and ensures staff’s adherence to Company policies and procedures.
• Manages, modifies, and maintains a complete and comprehensive quality system to support development and contract manufacturing of medical products.
• Oversees the technical side of the Company’s quality system and processes in relation to new product development and process improvement projects.
• Oversees the implementation of new products against market and technical standards.
• Evaluates the product manufacturing process and systems to ensure quality standards and timely and efficient flow of assigned projects.
• Implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Participates in the reviewing of engineering designs to contribute quality requirements and considerations and supports areas in gathering and analyzing data.
• Develops product/organizational quality assurance strategies including new European standards (MDSAP) where applicable.
• Develops and analyzes reports related to department metrics.
• Prepares and presents organizational performance and technical information to the management team and associates.
• Refines and implements quality product process plans and systems.
• Develops and reviews standard operating procedures (SOPs) and other required policies.
• Serves as quality engineering subject matter expert.
• Serves as the quality representative on new product introduction teams.
• Assures validation and compliance of contract manufacturing and sterilization facilities.

Qualifications

• Minimum Qualifications:
• Bachelor’s degree in a related engineering discipline.
• Minimum seven (7) years of related quality assurance experience.
• Previous management and leadership experience.
• Advance knowledge with development and test requirements with recognized standards (ISO 13485).
• Previous experience with New Product Development.
• Demonstrated knowledge of the application of regulatory requirements for low-risk and high-risk software applications using a scalable approach.
• Demonstrated knowledge and understanding on regulations and guidance as related to software development, SaMD.
• Demonstrated ability to implement and improve Software QMS processes.
• Previous quality assurance experience in materials manufacturing, preferred.