Controlled Environment Assembler

2 weeks ago


Oklahoma City, Oklahoma, United States JobRialto Full time

Position Overview:

The primary responsibility of a Cleanroom Assembler is to execute light assembly, ensure cleanliness, inspect, and package products within a controlled setting or designated area such as a non-sterile packaging station.

This role may also encompass boxing and palletizing finished products, preparing them for distribution as either non-sterile or sterile items. Adherence to all regulatory guidelines, including company policies and safety protocols, is essential in maintaining a clean and safe work environment.

Team Collaboration:

This position requires active participation in a team-oriented atmosphere, taking direction from a team coordinator, leader, supervisor, or manager.

Health and Safety Compliance:

Adherence to all health, safety, and environmental regulations, procedures, and job hazard assessments relevant to assigned tasks is mandatory, including medical evaluations as dictated by job functions.

Key Responsibilities:

(80%) Assemble and package medical products utilizing various methods:

- Interpret product specifications and blueprints.
- Verify component counts, quantities, and revisions.
- Clean components in preparation for packaging.
- Assemble products through bonding, winding, crimping, pressing, splitting, cutting, etc.
- Generate and affix labels for proper material identification.
- Seal products using diverse heat-sealing machines and materials such as Tyvek, mylar, PET, PEG, foil, non-sterile plastic, and blister packaging configurations.
- Box and prepare products for shipment to sterilization facilities.


(10%) Additional Duties:

- Assist with rework as necessary.
- Collaborate with quality/materials teams to trim or sort components.
- Perform other related tasks as assigned.


(5%) Documentation Compliance:

- Complete and comprehend documentation necessary to adhere to company policies, Quality Manual, and procedures, including FDA, QSR, and various domestic and international standards.
- Conduct work transactions and barcode scanning where applicable.


(5%) Team Skills:

- Communicate effectively both verbally and in writing.
- Exhibit listening skills, collaboration, and interpersonal harmony.

Qualifications:

- High School diploma or equivalent required.

- Previous experience in cleanroom or medical packaging is preferred.

- Ability to assemble and manage small components is essential.

- Proficiency in reading and writing English and basic math skills is required.



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