Quality Control Inspector - 2nd shift

SUMMARY:

To assist in maintaining Quality Assurance and Control practices in adherence to the Food and Drug Administration (FDA) regulations for the Quality System Regulation and for ISO 13485 standards, the QC Process Inspectors are responsible for conducting quality audits on in manufacturing process of IOLs to ensure that they meet required specifications. This role is also responsible for analyzing data and forming solutions to any issues that may arise from during the machining, tumbling and cleanroom completed audits. The role may involve additional responsibilities and opportunities as they become necessary and/or are assigned by quality management.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Monitor daily operations as assigned to ensure compliance to established procedures, specifications and/or Work Order instructions.
• Perform machining, tumbling and cleanroom in process audits per approved procedures.
• Identify and report unusual quality conditions to Quality Management employees for correction.
• Initiate NCRs for non-conforming product, out-of-specification processes, in process failures, etc.
• Assist Operations Group Leaders and Machine Operators as necessary to perform in-process checks, comply with Work Order instructions and implement corrective actions for process trends and/or non-compliance reporting.
• Verify equipment calibration per established procedures and frequencies as directed.
• Ensure adherence to company employee safety, GMP and GDP policies.

QUALIFICATIONS
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

• HS Diploma or equivalent; Associates a plus
• 2 – 3 years QC inspection experience in a regulated industry.
• Basic computer skills including proficiency in MS Office Products (Outlook, Word and Excel).
• Good communication skills.
• Detail oriented, excellent record keeping and documentation skills.

LANGUAGE SKILLS
English required, bi-lingual a plus. Ability to read and comprehend instructions, correspondence and memos. Ability to communicate effectively both in writing and verbally. Ability to effectively present information in one-on-one and small group situations to other employees of the organization.

MATHEMATICAL SKILLS
Ability to add, subtract, multiply, and divide in all units of measures, using whole numbers, common fractions, and decimals.

REASONING ABILITY
Ability to apply common sense understanding to carry out instructions. Ability to deal with and solve problems and be decisive.

OTHER SKILLS AND ABILITIES AND TRAITS
Basic computer skills is a plus. Energetic, self-motivating, team player, and can perform duties with minimal supervision.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is;

Occasionally exposed to: fumes or airborne particles, moving mechanical parts and vibration.

The noise level in the work environment can be loud. The temperature in the environment is not temperature controlled.

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.

Light to moderate physical effort required;

Must be able to regularly lift and /or move up to 5-15 pounds.

Frequently required to stand

Regularly required to walk

Repetitive use of hands; simple grasping, controlled grasping and fine manipulation

Specific vision abilities required by this job include; Close vision, Distance vision, Peripheral vision, Depth perception and Ability to adjust focus.

Position Type/Expected Hours of Work

This is a full-time position. Hours of work are Monday through Friday, 3:30pm to 12:00 a.m., half hour lunch, 40 hours per week.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Employee discount
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Evening shift

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Ontario, CA 91761: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• All employees are required to be vaccinated against COVID-19. Are you vaccinated against COVID-19 or willing to be vaccinated?

Education:

• High school or equivalent (Required)

Shift availability:

• Night Shift (Required)

Work Location: One location

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