| Excelsior Medical Corporation Job Description JOB TITLE: Cleanroom SwabCap XT Assembly Machine Operator Salary: The position pays between $11.00 to $12.50 hour depending on what shift you work. The shifts are 1, 2, or 3. SUMMARY: To operate SwabCap XT assembly machine inside cleanroom in the most effective, safest and productive manner in compliance with the Quality Systems to produce quality product.This includes US FDA regulations as required by the QS regulations and the CFR part 820 for medical devices, ISO 13485: 2003 and the Canadian Medical Devices Regulations and European Community Medical Device Directives 93/42/EEC of June 14, 1993 (MDD) requirements and subsequent revisions. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following (other duties may be assigned): - Operate Swab Cap assembly machine according to pertinent standard operating procedures, quality procedures / regulations and current good manufacturing practices.
- Complete all DHR documentation and verify segregation of Swab Cap assembly lots.
- Verify component correctness; part numbers, expiration date on foam and 70% isopropyl alcohol and lot numbers for all raw materials according to procedures.
- Ensure that raw materials have been inspected by AQL and approval labels are on, which indicate the materials have been released to the manufacturing department from the quality department before transferring raw materials into clean room G according to procedures.
- Load raw materials, change foil rolls and prepare finished SwabCap assemblies for shipment to Steris according to procedures.
- Perform daily and bi-weekly cleanings and line clearance according to procedures.
- Periodic visual Inspections to ensure that there are no defects in finished SwabCap assemblies.
- Removal of any and all components that would be considered rejects, as per the SOP.
- Supports the Mechanic when needed.
- Responsible for working safely and producing quality product. .
- Ensure to do all possible to minimize downtime and raw material losses.
- Keeps work area clean.
- Responsible for the care and condition of any assigned company tools, equipment and PPE.
- Performs, as required, other duties incidental to the position as may apply to the existing job description.
- Change into cleanroom dedicated shoes and nonsterile garments (apply head cover/ shoe covers / body garment/ face mask and sterile gloves )
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE - H.S. Diploma or equivalent
LANGUAGE SKILLS: - Ability to actively and effectively communicate verbally and in writing in English
MATHEMATICAL SKILLS: REASONING ABILITY: - The job requires the ability to make logical decisions in a fast pace environment. .
- The ability to problem solve is essential.
CERTIFICATE, LICENSES, REGISTRATIONS: Education documentation is required. Any other licenses or registrations to Professional Societies are to be provided by the candidate at his/her discretion. OTHER SKILLS and ABILITIES: - Ability to follow directions from Mechanic / Supervisor / Manager Area
- Team Player / Proactive
- Flexibility and adaptability to changes
- Good interpersonal skills with the ability to work well with others
- Strong attention to detail
- Basic computer skills with proficiency in MS Office application is a plus
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. | 
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