Production Builder I
$18 - $23 per hourPenumbra CPA
General Summary Under supervision, the Production Builder I performs moderately complex assembly. Performs data recording and product testing. Specific Duties and Responsibilities
*Indicates an essential function of the role
Position Qualifications Minimum education and experience:
- 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. >
*Indicates an essential function of the role
Position Qualifications 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 >
- 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 >
- Production lab/ Controlled Environment Room (CER) >
- Personnel are gowned and work in a class 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 extensive period of time each day. Will need to use a computer for email, trainings, procedures, etc. >
- Must be able to communicate and exchange accurate information with employees at all levels on a daily basis. >
Vacancy posted 2 days ago
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