Manager - Quality Assurance Engineering

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.