Production Builder I

Doist; Salt Lake City (UT); On-site; USD 24,796 - 31,684; Full time

Job summary

Doist in Salt Lake City, UT is seeking a Production Builder I to perform moderately complex assembly of medical devices under supervision, record data, and conduct product testing in a controlled cleanroom. You will work with microscopes and hand tools, following QMS, cGMP/QSR standards, and safety policies.

Minimum requirements include a high school diploma or equivalent with 1+ year clean room or manufacturing experience, basic math, and strong attention to detail.

Qualifications

• High School or equivalent with 1+ year clean room assembly experience or manufacturing experience in the medical device or biotech industry.
• Basic math skills and ability to understand English (spoken and written).
• Attention to detail and good communication skills.
• Familiarity with cGMP/QSR requirements and applicable regulations.

Responsibilities

• Assemble medical devices in accordance with QSR, ISO 13485, and SOPs.
• Perform in-process inspection to verify quality conformance.
• Record information on lot history records and manage component accountability.
• Set up and operate manufacturing equipment and maintain cleanroom standards.
• Report causes of process or documentation issues and assist in resolution.
• Maintain training records and adhere to QMS and regulatory requirements.

Skills

Basic math skills

Able to comprehend spoken and written 

Effective verbal and written

Attention to detail

Basic Working knowledge of cGMP/QSR

Education

High School or equivalent with 1+ year clean room assembly experience or manufacturing experience in the medical device, pharmaceutical or biotech industry

Tools

Microscope

Soldering iron

Tweezer

Job description

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General Summary

Under supervision, the Production Builder I performs moderately complex assembly. Performs data recording and product testing.

Specific Duties and Responsibilities

• Assemble medical devices according to Federal QSR, ISO 13485, lot history records, manufacturing instructions, standard operating procedures, and safety policies. *
• Perform in-process inspection of components and assemblies to verify quality conformance. *
• Record information on lot history records and performcomponentaccountabilities. *
• Set-up andoperatemanufacturing equipment. *
• Maintain cleanroom standards, practices, and housekeeping according to standard operating procedures and the illness and injury prevention program. *
• Clean supplies and manufacturing equipment and work areas. *
• Reportscausesof process and/or documentation issues andassistsin resolution. *
• Responsible forcompletionof personal training records.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
• Understand relevant security,privacyand compliance principles and adhere to the regulations, standards, and procedures thatare applicableto the Company. *
• Ensure other members of the departmentfollowthe QMS, regulations, standards, and procedures. *
• Frequent use of microscope*
• Perform other work-related duties as assigned.
• *Indicatesan essential function of the role

Position Qualifications

Minimum education andexperience:

• High School or equivalent with 1+ year clean room assembly experience or manufacturing experience in the medical device, pharmaceutical or biotech industry, or equivalent combination of education and experience required to perform at this level.
• Basic math skills
• Able to comprehend spoken and written English
• Effective verbal and written communication skills
• Able to pay close attention to detail
• Basic Working knowledge of cGMP/QSR requirements.
• Able to use tools such as microscope, soldering iron, tweezer, and other hand-held tools

Working Conditions

Production lab/ Controlled Environment Room (CER)

Personnel are gowned and work in aclass10,000 cleanroom

Willingness and ability to work on site.

Potential exposure to blood-borne pathogens

Requires some lifting and moving of up to 25 pounds

Must be able to move between buildings and floors.

Must be able to remain stationary and use a microscope, cleanroom or laboratory equipment, or other standard office equipment, for an extensiveperiod of timeeach day. Will need to use a computer for email, trainings, procedures,etc.

Must be able to communicate and exchangeaccurateinformation with employees at all levelson a daily basis.

Salt Lake City, UT

Day Shift

Base Pay Range Per Hour: $18.00 - $23.00

Individual compensation will vary over time based on factors such as performance, skill level, competencies, work location and shift.