Manager - Quality Assurance Engineering

Prismatik; Irvine (CA); On-site; USD 114,000 - 152,000; Full time

Job summary

Prismatik in Irvine, CA is seeking an experienced Quality Assurance Director to lead product quality and regulatory compliance across development and contract manufacturing for medical products. This onsite role requires strong leadership and a proven track record in ISO 13485 and SaMD.

You will oversee a robust quality system, mentor staff, drive process improvements, manage audits, and coordinate with engineering and manufacturing to ensure timely delivery and adherence to standards.

Qualifications

• Minimum seven years of related quality assurance experience.
• Previous management and leadership experience.
• Experience with ISO 13485 and SaMD regulatory requirements.
• Experience with development, testing, and manufacturing of medical products.

Responsibilities

• Ensures products meet customer requirements and complies with US and international regulations.
• Manages new product development and process improvement projects.
• Hires, trains, develops, and reviews staff; sets goals for department.
• Coaches team in problem solving, decision making and process improvement.
• Addresses employee relations matters in coordination with HR.
• Maintains a complete and comprehensive quality system for development and contract manufacturing.
• Oversees quality system processes during new product introductions.
• Evaluates manufacturing processes to ensure quality and timely project flow.
• Implements inspection, testing, and evaluation methods for products and equipment.
• Participates in audits and ensures SOPs and policies are followed.

Skills

Quality assurance

Leadership

Problem solving

Regulatory compliance

Education

Bachelor’s degree in a related engineering discipline

Job description

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.