Manager - Quality Assurance Engineering

About the Role

This position oversees product quality, regulatory compliance, and team leadership within a medical product development and contract manufacturing environment.

Responsibilities

• Ensures products meet customer requirements and comply with US and international regulations.
• Manages new product development and process improvement projects.
• Hires, manages, trains, develops, reviews, and sets goals for department staff.
• Acts as coach and mentor to team members in problem solving, decision-making, and process improvement.
• Addresses employee relations matters in coordination with Human Resources.
• Ensures staff adherence to Company policies and procedures.
• Manages and maintains a comprehensive quality system for medical product development and contract manufacturing.
• Oversees the technical side of the quality system and processes for new product development and process improvement.
• Oversees implementation of new products against market and technical standards.
• Evaluates product manufacturing processes and systems to ensure quality standards and efficient project flow.
• Implements methods and procedures for inspecting, testing, and evaluating product precision and accuracy.
• Participates in reviewing engineering designs to contribute quality requirements and considerations.
• Develops product and organizational quality assurance strategies, including new European standards (MDSAP).
• Develops and analyzes reports related to department metrics.
• Prepares and presents organizational performance and technical information to management 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 and representative on new product introduction teams.
• Assures validation and compliance of contract manufacturing and sterilization facilities.
• Manages Quality Engineering activities and organizes related procedures and documentation.
• Participates in internal, external, and third-party audits.
• Provides technical assistance on specifications, regulations, material qualifications, and quality-related subjects.
• Performs other related duties and projects as directed by management.

Requirements

• Bachelor’s degree in a related engineering discipline.
• Minimum seven (7) years of related quality assurance experience.
• Previous management and leadership experience.
• Advanced knowledge of development and test requirements with recognized standards (ISO 13485).
• Previous experience with New Product Development.
• Demonstrated knowledge of regulatory requirements for low-risk and high-risk software applications using a scalable approach.
• Understanding of regulations and guidance related to software development and SaMD (Software as a Medical Device).
• Ability to implement and improve Software QMS (Quality Management System) processes.
• Previous quality assurance experience in materials manufacturing (preferred).

Pay

$114,062.25 – $152,083.00 per year. Exact compensation may vary based on skills and experience.

Schedule

This role is fully onsite at the Irvine, CA campus. Remote or hybrid arrangements are not available.