Production Builder

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

• 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,privacy and compliance principles and adhere to the regulations, standards, and procedures thatare applicable to 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

Minimum education and experience:

• 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

Production lab/ Controlled Environment Room (CER)

Personnel are gowned and work in aclass
10,000 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.

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