Lead Quality Engineer

Position Overview

We are seeking a talented and motivated Principal Quality Engineer (or QA Manager) to join our team full-time at our Bay Area facility. This is an on-site position offering hands-on experience with cutting-edge medical device technology.

The Principal QE will be a key contributor responsible for providing practical quality engineering support for design and development, production, and general QMS activities.

The ideal candidate provides critical hands-on input and leadership across various quality functions including design controls, risk management, inspections, sterilization and testing.

The ideal candidate thrives in dynamic startup environments, brings strong organizational and documentation skills combined with a collaborative mindset, and is excited by the opportunity to make meaningful contributions to a product that will directly impact patient lives. This position offers the chance to shape the future of our technology and organization for the right individual.

Roles and Responsibilities

•

Provides Design Quality Assurance support throughout design, development, and production to ensure compliance to internal and external requirements and standards (ISO 13485, ISO 14708, IEC 60601 etc).

•

Serves as the quality expert for and is responsible for making key quality decisions including ownership of design control and document control systems.

•

Supports risk management activities based on ISO 14971 including risk management planning, hazard analysis and FMEAs (Failure Mode Effects Analysis) to evaluate and ensure product safety and functionality during development and production

•

Manages supplier quality including performing supplier qualifications. Also as needed, along with technical team, works with key suppliers to ensure compliance to product quality requirements and lead the resolution of product quality issues

•

Provide key quality input towards planning and execution of DV&V testing

•

Manages incoming parts inspections to ensure components meet product specifications

•

Works with sterilization vendor to outline device sterilization procedures and manages sterilization lot release activities

•

Support company goals and objectives, policies and procedures that are related to the Quality Management System and Quality System Regulations

Required Qualifications

•

Bachelor's degree in Engineering or related science field required

•

8+ years of design quality assurance experience within an FDA regulated environment

•

Demonstrable knowledge and working experience with Design Controls, Risk Management (Hazard Analysis), Design and Process FMEA, Statistical Analysis, Product Qualification, and Medical Device Product Release

•

Experience in medical device manufacturing environment with a strong working knowledge of QSR/cGMP, ISO 13485, ISO 14971and IEC 60601

•

Must be team oriented and have excellent communication and interpersonal skills

•

Self-directed problem solver with ability to balance independent work and collaborative cross-functional initiatives

•

Strong documentation practices

•

Prior role in an early-stage medical device company or startup environment

Preferred Qualifications

•

Experience with active implantable medical devices (AIMDs)

•

Knowledge of ISO 14708 requirements and tests for active implantable devices

•

Experience in the cardiovascular devices space