Production Builder I

Job description

**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 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. **Additional qualifications:** - 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 **Working Conditions** - 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.