Quality Operations Engineer

Danaher•Lodi, CA

4d•Onsite

About The Position

The Quality Operations Engineer supports day-to-day Manufacturing Quality activities by completing structured assignments using established procedures and under the guidance of senior Quality Engineering staff to help maintain compliance with the Quality Management System (QMS) and applicable regulations. This role contributes to product quality and sustaining operations by supporting investigations, documentation updates, and process improvement activities. This position reports to the Manager, Manufacturing Quality and is part of the Cepheid Quality Operations Team located in Lodi, California. This is an ON-SITE role supporting twenty-fourx7 manufacturing operations. Schedule: 5 days (Monday - Friday) – Day Shift

Requirements

Bachelor’s degree in an engineering or related field (e.g., Industrial, Biomedical, Molecular Biology, Mechanical), with 0–2 years of related experience (internship/co-op experience may be considered)
Foundational understanding of quality concepts and tools (or demonstrated ability to learn them quickly) and the ability to follow documented procedures in a regulated environment

Nice To Haves

Exposure to medical device or diagnostics regulations/standards (e.g., 21 CFR Part 820 and ISO 13485) and interest in learning how they are applied in manufacturing quality.
Experience working at a manufacturing facility (preferably high volume)
A quality engineering certification from the American Society for Quality (ASQ), or other qualifying organizations. Examples may include but are not limited to the CQE, CRE, CQA, etc.

Responsibilities

Quality point of contact assisting with day-to-day inquiries and escalations; gather information, document issues, and escalate to senior Quality/Manufacturing leadership as needed.
Participate in quality system and process improvement activities by collecting data, performing trending, and supporting GEMBA and problem-solving activities using established tools and templates.
Work with engineering and manufacturing teams to support process improvements and variability reduction by executing assigned tasks (e.g., data collection, document updates, and follow-up actions) under guidance.
Support process validations, process control plans, and statistical process control (SPC) activities by following documented protocols/work instructions and accurately recording results.
Support project teams by updating and maintaining quality documentation (e.g., inspection and manufacturing documents, test methods, and Device History Records (DHRs)) using established templates and review processes.
Support compliance activities related to design control and change control by preparing documentation, routing records for review/approval, and following established procedures.