Assembler, Instrument Production- San Diego

Werfen; Sorrento Valley (CA); On-site; USD 40,000 - 60,000; Full time

Job summary

A leading company in the medical device industry is seeking an Assembler to join their team. The role involves performing mechanical and electromechanical activities related to instrument assembly while ensuring compliance with quality standards. The ideal candidate will have practical experience in a production environment and a focus on quality and safe working conditions.

Qualifications

• Minimum 2 years previous instrument assembly experience in a regulated environment preferred.
• Competent in using various tools and assembly drawings.
• Familiarity with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) preferred.

Responsibilities

• Perform manufacturing activities of new instruments as directed.
• Conduct visual quality checks and incoming inspections.
• Maintain records as per Good Documentation Practices.

Skills

Soldering

Hand-eye coordination

Teamwork

Communication

Education

High school diploma or equivalent

Tools

Assembly jigs

Test fixtures

Job description

Overview

Position Summary:

The Assembler performs routine mechanical and electromechanical activities related to the assembly of instrument products.

Responsibilities

Key Accountabilities

Essential Functions:

• Perform new instrument manufacturing activities as directed.
• Continually work to achieve assigned goals; meet unscheduled peaks in workload as necessary to ensure timely release of product and to avoid back orders.
• Perform visual quality checks on sub-assemblies.
• Perform set-up and calibration of instruments.
• Perform incoming inspections of instrument electrical components and sub assemblies.
• Record information in device history records associated with new instrument.
• Identify line issues and other department problems; promptly notify Team Leader or Supervisor of required corrective action.
• Support all efforts and procedures to maintain optimal department conditions.
• Maintain accurate records and documentation in accordance with Good Documentation Practices (GDP) and all related SOPs.
• Always maintain safe working conditions; adhere to all safety policies and procedures.
• Ensure area, test equipment, and tools, kept cleaned and organized.
• Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures and processes.
• Other duties as assigned.

Qualifications

Minimum Knowledge & Experience Required for the Position:

• High school diploma or equivalent.
• At least two (2) years previous instrument assembly experience; previous experience in a regulated medical device manufacturing or pharmaceutical environment strongly preferred.
• Practical experience in a production environment assembling instruments.
• Ability to solder small components.
• Competent utilizing various test fixtures, assembly jigs, and tools.
• Ability to utilize assembly drawing.
• Familiarity with GDP and GMP a preferred.
• Excellent hand-eye coordination needed.
• Able to use desktop or laptop computer.
• Good written and verbal communication.
• Ability to work as part of a team.

NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means shall be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.