Production Builder I
Penumbra • Salt Lake City, UT14d • $18 - $23 • Onsite
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Production Builder I
Penumbra•Salt Lake City, UT
•$18 - $23•Onsite
About The Position
Under supervision, the Production Builder I performs moderately complex assembly. Performs data recording and product testing. Assembles medical devices according to Federal QSR, ISO 13485, lot history records, manufacturing instructions, standard operating procedures, and safety policies. Performs in-process inspection of components and assemblies to verify quality conformance. Records information on lot history records and performs component accountabilities. Sets-up and operates manufacturing equipment. Maintains cleanroom standards, practices, and housekeeping according to standard operating procedures and the illness and injury prevention program. Cleans supplies and manufacturing equipment and work areas. Reports causes of process and/or documentation issues and assists in resolution. Responsible for completion of personal training records. Adheres to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. Understands relevant security, privacy and compliance principles and adheres to the regulations, standards, and procedures that are applicable to the Company. Ensures other members of the department follow the QMS, regulations, standards, and procedures. Regular, reliable attendance onsite. Frequent use of microscope. Performs other work-related duties as assigned.
Requirements
- 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
- High manual dexterity
- Basic Working knowledge of cGMP/QSR requirements.
- Able to use tools such as microscope, soldering iron, tweezer, and other hand-held tools
- Regular, reliable attendance onsite
- Frequent use of microscope
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 perform component accountabilities.
- Set-up and operate manufacturing 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.
- Reports causes of process and/or documentation issues and assists in resolution.
- Responsible for completion of 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 that are applicable to the Company.
- Ensure other members of the department follow the QMS, regulations, standards, and procedures.
- Perform other work-related duties as assigned.
Benefits
- medical
- dental
- vision
- life
- AD&D
- short and long-term disability insurance
- 401(k) with employer match
- paid parental leave
- eleven paid company holidays per year
- a minimum of fifteen days of accrued vacation per year, which increases with tenure
- paid sick time in compliance with applicable law(s)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
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