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Quality Assurance Engineering Manager
1 month ago
About Prismatik Dentalcraft, Inc.
Prismatik Dentalcraft, Inc. is a leading manufacturer of dental products, and we are seeking a highly skilled Quality Assurance Engineering Manager to join our team.
Job Summary
The Quality Assurance Engineering Manager will be responsible for ensuring that our products meet customer requirements and comply with US and international regulations. This includes managing new product development and process improvement projects, as well as overseeing the technical side of our quality system and processes.
Key Responsibilities
- Develop and implement quality assurance strategies to ensure compliance with regulatory requirements.
- Manage and maintain a comprehensive quality system to support product development and contract manufacturing.
- Oversee the implementation of new products against market and technical standards.
- Evaluate the product manufacturing process and systems to ensure quality standards and timely and efficient flow of assigned projects.
- Implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
- Participate in the reviewing of engineering designs to contribute quality requirements and considerations.
- Develop and analyze reports related to department metrics.
- Refine and implement quality product process plans and systems.
- Develop and review standard operating procedures (SOPs) and other required policies.
- Serve as quality engineering subject matter expert.
- Assure validation and compliance of contract manufacturing and sterilization facilities.
- Manage Quality Engineering activities.
- Organize procedures and documentation related to areas of responsibility.
- Participate in internal, external, and third-party audits.
- Provide technical assistance to other functional areas regarding interpretation of specifications, regulations, material qualifications, first article evaluations, and other quality-related subjects.
Requirements
- 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).
- Previous quality assurance experience in materials manufacturing.
- 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.
Pay Range
$111,956-$155,000/yr
Exact compensation may vary based on skills and experience.
