Quality Engineering Technician

Location

Oakland, CA

$75,000.00 – $80,000.00 USD Annually

The Quality Engineering Technician is responsible for performing inspections of returned goods for root‑cause analysis and product/process improvement, as well as other QE‑related functions, under the direction of the Quality Engineer.

• Read drawings, wiring diagrams, instructions, and manufacturing documentation to inspect medical device products and components.
• Interpret documented customer complaints to support root‑cause analysis.
• Test and analyze products returned through the Returned Material Authorization (RMA) system by testing functionality, inspecting and measuring electronic circuits, and disassembling devices.
• Perform inspection of in‑process materials and release of assembled medical devices.
• Complete inspection documentation and notify supervisor and engineering of product discrepancies.
• Assist in Nonconformance Report (NCR) creation and follow‑up.
• Maintain inspection and nonconformance records for trending analysis.
• Follow cGMP and ISO requirements.
• Assist in technical functions related to product refurbishment.
• Maintain the inspection work area, documentation, and equipment in a clean and orderly condition and follow prescribed safety regulations.

Education, Experience and Training

2 years of Quality Inspection or QE/Engineering Technician experience in a medical device or similar regulated environment (e.g., aeronautical), or in the electronics industry.

• Understanding of basic electronics, including basic circuit components, soldering, and use of a multimeter.
• Excellent verbal communication skills.
• Demonstrable knowledge of GMP processes/procedures.
• Basic computer skills with MS Office (Outlook, Word, Excel).
• Ability to use precision measuring devices such as calipers, pin gauges, and micrometer.
• Manual dexterity and hand‑eye coordination needed to inspect medical devices, subassemblies and components.
• Ability to perform unaided and microscopic visual inspection.
• Some lifting to 40 lbs.
• Capability to use equipment such as microscope, mechanical and electrical assembly tooling & fixtures, adhesive dispenser, tweezers, crimpers, cutters and hand tools.
• Good teamwork, communication and interpersonal skills. A demonstrated commitment to company values.

Continuous Improvement, Problem Solving, Service Focus, Collaboration & Team, Communication, Change Agility, Mission & Vision Focus, Stewardship.

G Suite, Microsoft Office Suite, Adobe, Salesforce CRM, etc.

The physical functions described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers; handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus.

The noise level in the work environment is usually low to moderate.