Quality Assurance Engineering Manager

Prismatik Dentalcraft, a division of Glidewell Dental

About the role

Oversees the quality system and processes for new product development and contract manufacturing of medical products, ensuring compliance with US and international regulations.

Responsibilities

• Ensures products meet customer requirements and comply with regulatory standards.
• 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.
• Mantains and modifies a comprehensive quality system for medical product development and manufacturing.
• Oversees the technical aspects of the quality system for new product development and process improvement.
• Ensures implementation of new products meets market and technical standards.
• Evaluates manufacturing processes and systems to ensure quality and efficiency.
• Implements inspection, testing, and evaluation methods for product precision and accuracy.
• Reviews engineering designs to contribute quality requirements and considerations.
• Develops quality assurance strategies, including new European standards (MDSAP) where applicable.
• Analyzes and prepares reports on department metrics and presents performance data to management.
• Refines and implements quality product process plans and systems.
• Develops and reviews standard operating procedures (SOPs) and required policies.
• Serves as the 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 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 quality assurance experience in materials manufacturing.
• Previous experience with New Product Development.
• Demonstrated knowledge of regulatory requirements for low-risk and high-risk software applications.
• 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.

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.