Production Builder I

Penumbra•Salt Lake City, UT

5d•Onsite

About The Position

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 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. Regular, reliable attendance onsite. Frequent use of microscope. Perform 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

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.
Regular, reliable attendance onsite.
Frequent use of microscope.
Perform other work-related duties as assigned.