Quality Engineer III (PT position 20 hrs. week)

Job TitleQuality Engineer IIILocationSan Diego, CAContract Duration5+ monthsHours & Shift20 hours per week, 1st shift, onsite, not remotePart‑time position, flexible scheduling.Job DescriptionThe Quality Engineer III will support the BD Custom Technology Team's conversion from ISO 9001:2015 to ISO 13485:2016. As part of the project team, the role will identify gaps, prioritize actions using a risk‑based approach, and implement required changes. The position will apply ISO standards to develop and implement solutions of moderate scope and complexity. Working independently and with process and equipment subject matter experts, the role will revise existing procedures and draft new procedures under the guidance of the project team.A minimum of 2 years of prior medical device experience applying Design Control under ISO standards is required. A degree in biology or chemistry with industry application experience in antibody manufacturing and/or immunology is preferred. The successful candidate will be a strong oral and written communicator with expertise in risk assessment techniques (FMEA, etc.), process validation, environmental controls, and quality systems.Top Skills RequiredDocumented knowledge of and experience with ISO 9001 and/or ISO 13485Medical device risk analysis and validation experienceStrong Microsoft Office skills including Word, Excel and VisioProject experience in a lead or responsible member capacityAssertive ability to communicate with SMEs to define processes#J-18808-Ljbffr