Job Title: Quality Engineer

Job Description

We are seeking a Quality Engineer with a background in design transfer and sustaining engineering to support the launch and scale-up of a new medical device. This role requires close collaboration with Manufacturing Engineering to ensure a seamless transition from design to production, emphasizing quality systems, risk management, and regulatory compliance.

Responsibilities

• Work closely with the manufacturing engineer to ensure the client's design is accurately translated onto the manufacturing line.
• Conduct risk assessments and execute FMEA testing.
• Perform sterilization (Gamma type) on products.
• Create and manage Bill of Materials (BOM).
• Verify that equipment or systems are installed correctly and according to manufacturer specifications (IQ).
• Confirm that the equipment or system operates as intended across all specified operating ranges (OQ).
• Demonstrate that the entire process, using the qualified equipment, consistently produces acceptable products under real-world conditions (PQ).

Essential Skills

• Proven experience in design transfer.
• Experience with risk assessments and FMEA testing.
• Knowledge of quality management systems (QMS).
• Proficiency in IQ, OQ, PQ processes.
• Experience working with metal and steel hardware.

Additional Skills & Qualifications

• Experience with orthopedic companies or surgical robotic companies.
• Familiarity with sterilization processes, specifically Gamma type.

Work Environment

Located in Fremont, CA, this position offers the opportunity to work at two distinct sites: a contract manufacturing plant and a design and development lab. The design and development site is currently expanding and gaining more NPI projects, providing exposure to innovative products in pre-commercialization as well as overseeing sustaining projects post-commercialization.