Quality Assurance Manager in Engineering

2 weeks ago

Irvine, California, United States PRISMATIK DENTALCRAFT, INC. Full time

About Prismatik Dentalcraft:

Prismatik Dentalcraft, a division of Glidewell Dental, is dedicated to delivering exceptional quality in the dental industry.

Key Responsibilities:

  • Ensure that products fulfill customer expectations and adhere to both US and international standards. Oversee new product initiatives and enhance existing processes.
  • Recruit, manage, train, and develop team members while setting clear objectives for the department.
  • Act as a mentor and coach to team members, fostering skills in problem-solving, decision-making, and process enhancement.
  • Address employee relations issues promptly in collaboration with Human Resources.
  • Ensure compliance with company policies and procedures among staff.
  • Develop, modify, and maintain a thorough quality management system to support the development and contract manufacturing of medical products.
  • Supervise the technical aspects of the company's quality system and processes related to new product initiatives and process improvements.
  • Manage the rollout of new products in alignment with market and technical benchmarks.
  • Assess the manufacturing processes and systems to guarantee quality standards and the efficient progression of assigned projects.
  • Establish methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
  • Contribute to engineering design reviews by providing quality requirements and considerations, while assisting in data collection and analysis.
  • Formulate quality assurance strategies for products and the organization, including compliance with new European standards (MDSAP) as applicable.
  • Analyze departmental metrics and prepare reports to present organizational performance and technical data to management and staff.
  • Refine and implement quality product process plans and systems.
  • Develop and review standard operating procedures (SOPs) and other necessary policies.
  • Serve as the subject matter expert in quality engineering.
  • Act as the quality representative on teams for new product introductions.
  • Ensure validation and compliance of contract manufacturing and sterilization facilities.
  • Oversee Quality Engineering operations.
  • Organize documentation and procedures related to areas of responsibility.
  • Participate in internal, external, and third-party audits.
  • Provide technical guidance to other departments regarding specifications, regulations, material qualifications, first article evaluations, and other quality-related topics to enhance understanding of SOPs and guidance documentation.
  • Perform additional related duties and projects as required by management.

Qualifications:

  • Bachelor's degree in a relevant engineering field.
  • A minimum of seven (7) years of experience in quality assurance.
  • Prior management and leadership experience.
  • Advanced knowledge of development and testing requirements in accordance with recognized standards (ISO).
  • Experience in quality assurance within materials manufacturing.
  • Familiarity with New Product Development processes.
  • Proven understanding of regulatory requirements for both low-risk and high-risk software applications, employing a scalable approach.
  • In-depth knowledge of regulations and guidance related to software development, including SaMD.
  • Demonstrated capability to implement and enhance Software Quality Management System (QMS) processes.

Compensation: The pay range for this position is $111,956-$155,000 per year, with exact compensation varying based on skills and experience.

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