Engineer
Company: Spectrum Assembly Inc
Location: Carlsbad
Posted on: April 20, 2024
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Job Description:
Growing contract manufacturer in San Diego County is seeking
experienced and motivated Quality Engineer to join Engineering
team. The Quality Engineer is responsible for supporting the
manufacturing process, creating, implementing, evaluating
improvement initiatives; to ensure delivery of the highest quality
product to the customer. Responsibilities : Coordinates with
quality and engineering personnel to ensure compliance with
internal policies and procedures as well as to applicable external
standards (GMP, QSR, ISO 13485, etc.). Performs quality review and
approval of regulated documentation including, but not limited to,
part/component/system inspection reports, nonconforming material
reports, deviations, engineering change orders, engineering change
reports, and engineering work orders. Reviews and approves supplier
documentation (protocols, reports, specifications, etc.), as
defined in the Quality Agreement. Responsible for adherence to
supplier and customer Quality Agreement provisions. Verifies,
creates and/or revises SOPs, work instructions and associated
forms, and participates in the implementation of these procedures.
Verifies engineering tests and measurement practices for new and
existing products using appropriate tools. Manages the CAPA,
Complaints, Non-Conforming Material, Deviation systems; including
generating Quality metrics. Reviews drawings for adherence to
design inputs, design control procedures, regulatory standards, and
quality system requirements. Provides quality oversight for product
release and shipping activities. Reviews and approves Device
History Records for finished device release as required. Assist
Quality Manager in creating and revising standard operating
procedures, as needed. Ensure employees follow procedures; perform
ongoing gap analysis and work with managers to assign employee
training. Lead internal audits and participate in and support
external customer/regulatory audits as needed. Ensure quality and
regulatory requirements are successfully implemented and
maintained. Present issues, trends, and feedback clearly at CAPA
Meetings. Actively track CAPA's, as needed, and remain diligent to
ensure the tasks are completed on time. Identify and control
manufacturing process defects (scrap, nonconforming material,
custom complaints) by identifying the primary root causes and
implementing corrective and preventative actions. Experience/Skill/
Education: Experience working with CAPA, Management Review, Change
Control and Audit processes. Working knowledge of 21CFR 820, and
ISO 13485, AS9100 quality requirements and military specifications
Previous experience with effective root cause investigation,
corrective and preventive action planning. Experience with quality
tools and process improvement techniques. Experience reviewing
technical documentation. Strong written and verbal communication
skills Strong critical thinking and analytical skills Ability to
read and interpret blueprints, technical drawings, schematics, and
computer-generated reports. Bachelor's Degree in electronics
engineering preferred with 5+ years of experience in manufacturing,
or equivalent combination of education, training, and relevant work
experience may be considered. Working knowledge of IPC-A-610,
J-STD-001 Experience with the Medical Device Industry and the
industry preferred We offer excellent benefits, every other Friday
off, and a great working environment. To apply please send resume.
Employment Type: Full Time Years Experience: 5 - 10 years Salary:
$93,600 - $100,000 Annual Bonus/Commission: No
Keywords: Spectrum Assembly Inc, Burbank , Engineer, Engineering , Carlsbad, California
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