Glidewell

Manager - Quality Assurance Engineering

Glidewell • $114K — $152K *
Irvine, CA 92620In-Person
Healthcare
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a related engineering discipline.
  • Minimum of 7 years in quality assurance, specifically in medical products.
  • Prior management and leadership experience in a technical environment.
  • Advanced knowledge of ISO 13485 and relevant development/test standards.
  • Experience with New Product Development in compliance with regulatory standards.
  • Expertise in software regulations, specifically SaMD and its quality management systems.
  • Background in materials manufacturing quality assurance is preferred.

Responsibilities

  • Ensure compliance with US and international regulations for product development.
  • Hire, train, and manage department staff while setting goals and objectives.
  • Act as a coach and mentor to enhance problem-solving and decision-making skills among the team.
  • Address employee relations issues promptly in collaboration with HR.
  • Oversee the implementation of a comprehensive quality system for medical products.
  • Evaluate and refine manufacturing processes to meet strict quality standards.
  • Lead quality assurance efforts for new product introduction teams.

Benefits

  • Comprehensive health benefits package.
  • Opportunities for professional development and training.
  • 401(k) retirement savings plan with company match.
  • Paid time off and holidays to promote work-life balance.
Full Job Description
Description

Position at Prismatik

Essential Functions:
  • 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.
  • Manages Quality Engineering activities.
  • Organizes procedures and documentation related to areas of responsibility.
  • Participates in internal, external, and third party audits.
  • Provides technical assistance to other functional areas regarding interpretation of specifications, regulations, material qualifications, first article evaluations, and other quality related subjects to increase understanding of SOPs and guidance documentation.
  • Performs other related duties and projects as business needs require at direction of management.

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.

Pay range: $114,062.25 - 152,083.00/yr

Exact compensation may vary based on skills and experience.

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

About Glidewell

Glidewell is a privately owned dental technology company that provides dental products, services, and education to dental professionals. The company is based in Newport Beach, California and has additional locations in Irvine, California; Louisville, Kentucky; and Dallas, Texas. Glidewell is known for its innovative dental products and services, including BruxZir Solid Zirconia, the most prescribed brand of full-contour zirconia in North America.
Learn more about Glidewell
Size
6,000 employees
Industry
Healthcare
Founded
1970
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Glidewell

More Healthcare Jobs

Find similar Manager - Quality Assurance Engineering jobs:

NationwideIrvine, CA