Essential Functions:
- Ensures products meetcustomerrequirementsandcomplieswithUSand internationalregulations. 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.
- Developsandreviewsstandard operating procedures (SOPs)andother 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, andthird party audits.
- Provides technical assistance to other functional areas regarding interpretation of specifications, regulations, material qualifications, first article evaluations, and other quality related subjectsto increase understanding of SOPsand guidancedocumentation.
- Performsother 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.
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