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Company

Original Job Post

Fong’s Engineering and Manufacturing Pte Ltd · 4 days ago

Process Engineer

Irvine, CA

Full-time

Onsite

Mid Level

2+ years exp

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Industrial ManufacturingMachinery Manufacturing

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Responsibilities

Perform product trainings for repair center technicians & staff.

Assemble and disassemble small delicate parts of medical devices to meet specifications.

Ensure internal activities and partnerships adhere to regulations and quality standards.

Apply quality and regulatory standards to medical equipment and process qualification.

Interpret internal requirements and write SOPs and work instructions.

Diagnose problems, replace or repair parts, test, and make adjustments.

Provide CAPA, complaints, audit, and overall QMS support.

Perform final quality inspection on completed repairs.

Troubleshoot potential problems and operate equipment safely.

Adhere to safety policies and procedures.

Comply with FDA and ISO standards.

Qualification

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Electronic certificationMechanical certificationMedical repair experienceEndoscopy field experienceSolderingMeeting targetsDiscrepancy resolutionInformation analysisDocument analysisProblem-solvingHard-workingCommunicationAnalyticalPrioritizationPresentation

Required

Electronic and/or Mechanical Certification or degree. Plus 2-5 years’ experience working in a medical repair or similar environment preferably in the endoscopy field.

Electronic and mechanical skills required.

Solder skills and experience required.

Must follow instructions and apply to real situations in a very quick manner.

Reach monthly targets on a consistent basis.

Ability to meet and/or exceed deadlines.

Able to professionally communicate with internal and external customers.

Able to investigate and resolve discrepancies.

Ability to research and analyze various different types of information.

Ability to prioritize work.

Ability to read, analyze, and interpret essential job-related documents.

Ability to present and speak effectively and professionally to employees of the organization.

Ability to calculate and match figures and amounts.