QA Engineering Manager - Medical Devices (Onsite)

PRISMATIK DENTALCRAFT, INC.; Irvine (CA); On-site; USD 114,000 - 152,000; Full time

Job summary

Prismatik Dentalcraft, Inc. in Irvine, CA is seeking a Senior Quality Engineer or Quality Engineering Manager to lead the QA team and ensure regulatory compliance for medical products.

You will drive the development and maintenance of the quality system, oversee contract manufacturing, and coordinate audits while advancing New Product Development and Software QMS initiatives (SaMD). This onsite role requires strong leadership and deep regulatory knowledge.

Qualifications

• Bachelor's degree in a related engineering discipline.
• Minimum seven years of related quality assurance experience.
• Previous management and leadership experience.
• Advanced knowledge with 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 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.

Responsibilities

• Lead and manage QA staff and set department goals.
• Oversee quality system for medical products and contract manufacturing.
• Ensure compliance with US and international regulations.
• Coordinate audits and provide cross-functional QA support.
• Develop QA strategies including new European standards (MDSAP).
• Present department metrics and performance to management.

Skills

Leadership

Quality assurance

Regulatory knowledge

Software quality management

Education

Bachelor’s degree in engineering

Tools

ISO 13485

Software QMS

Job description

Prismatik Dentalcraft, Inc. in Irvine, CA is seeking a Senior Quality Engineer or Quality Engineering Manager to lead the QA team and ensure regulatory compliance for medical products.

You will drive the development and maintenance of the quality system, oversee contract manufacturing, and coordinate audits while advancing New Product Development and Software QMS initiatives (SaMD). This onsite role requires strong leadership and deep regulatory knowledge.