Job description

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: $114,000 - 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.

Requirements

Must-haves

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.
Performs other related duties and projects as business needs require at direction of management.
Bachelor’s degree in a related engineering discipline.

Nice-to-haves

Previous quality assurance experience in materials manufacturing, preferred.

Application prep

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Platform: jobvite
Effort: medium