Essential Functions:
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Ensures products meet customer requirements and complies with US and international regulations. Manages new product development and process improvement projects.
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Hires, manages, trains, develops, reviews, and set goals for department and staff.
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Acts as both coach and mentor to team members in areas of problem solving, decision-making, and process improvement.
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Addresses all employee relations matters in a timely manner in coordination with Human Resources.
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Manages and ensures staff’s adherence to Company policies and procedures.
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Manages, modifies, and maintains a complete and comprehensive quality system to support development and contract manufacturing of medical products.
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Oversees the technical side of the Company’s quality system and processes in relation to new product development and process improvement projects.
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Oversees the implementation of new products against market and technical standards.
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Evaluates the product manufacturing process and systems to ensure quality standards and timely and efficient flow of assigned projects.
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Implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
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Participates in the reviewing of engineering designs to contribute quality requirements and considerations and supports areas in gathering and analyzing data.
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Develops product/organizational quality assurance strategies including new European standards (MDSAP) where applicable.
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Develops and analyzes reports related to department metrics. Prepares and presents organizational performance and technical information to the management team and associates.
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Refines and implements quality product process plans and systems.
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Develops and reviews standard operating procedures (SOPs) and other required policies.
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Serves as quality engineering subject matter expert.
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Serves as the quality representative on new product introduction teams.
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Assures validation and compliance of contract manufacturing and sterilization facilities.
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Manages Quality Engineering activities.
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Organizes procedures and documentation related to areas of responsibility.
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Participates in internal, external, and third party audits.
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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.
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Performs other related duties and projects as business needs require at direction of management.
Minimum Qualifications:
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Bachelor’s degree in a related engineering discipline.
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Minimum seven (7) years of related quality assurance experience.
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Previous management and leadership experience.
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Advance knowledge with development and test requirements with recognized standards (ISO 13485).
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Previous experience with New Product Development.
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Demonstrated knowledge of the application of regulatory requirements for low-risk and high-risk software applications using a scalable approach.
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Demonstrated knowledge and understanding on regulations and guidance as related to software development, SaMD.
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Demonstrated ability to implement and improve Software QMS processes.
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Previous quality assurance experience in materials manufacturing, preferred.
Pay range: $114,000 - 152,000/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.
