Production Builder I

Penumbra; Salt Lake City (UT); Vor Ort; USD 38.000 - 48.000; Vollzeit

Zusammenfassung

Penumbra in Salt Lake City is seeking a Production Builder I to assemble medical devices under supervision, perform data recording and product testing, and set up manufacturing equipment in a cleanroom environment.

You will maintain strict QMS and ISO13485 compliance, record lot histories, ensure accuracy, and uphold safety and housekeeping standards with reliable onsite attendance.

Qualifikationen

• 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 and English comprehension.
• Strong attention to detail and effective verbal and written communication skills.
• Familiarity with cGMP/QSR requirements.

Aufgaben

• 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 SOPs and safety programs.
• Clean supplies and manufacturing equipment and work areas.
• Adhere to the Company's QMS and quality system regulations and procedures.
• Ensure other department members follow QMS, regulations, standards, and procedures.
• Frequent on-site attendance and use of microscope.
• Perform other work-related duties as assigned.

Kenntnisse

Basic math

English proficiency

Verbal communication

Written communication

Attention to detail

Manual dexterity

cGMP knowledge

Ausbildung

High School diploma or equivalent

Tools

Microscope

Soldering iron

Tweezers

Hand-held tools

Jobbeschreibung

Responsibilities

As a Production Builder/Medical Device Assembler, you will be part of a dynamic team helping make products that save lives every day.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

Qualifications

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