Quality Engineer

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.

Skills

Experience/Skills/ 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

Contact Details

Name: Maria Tuell
Address: 6300 Yarrow Dr.
City: Carlsbad
State/Province: California
Zipcode: 92011
Country: United States
Ph: 7609304000
Email: [email protected]