Quality Assurance Assistant II
About The Position
Responsibilities: Follow quality rules for proper gowning, cleaning, or other tasks. Assist with operational projects and assignments. Provide support on regulatory inspections, audits, investigations, and inquiries regarding the control, assessment, risk management and corrective and preventive actions of manufacturing quality. Collaborate with manufacturing and engineering departments to review processes for new and existing procedures, validations, inspections, and training. Collaborate with tool engineering department to verify tooling check in, tagging, and tool identification. Prepare documentation to enhance consistency throughout the manufacturing process and identify areas of improvement. Develop, maintain and implement quality procedures. Perform environmental monitoring including cleanroom testing. Monitor pest control program. Maintain database entries and records. Support CAPA program and provide follow-up to ensure corrective measures are taken. Collaborate with service vendors to ensure calibration cycles are maintained and calibrations are performed. Conduct internal calibrations as needed. Participate as an internal auditor. Perform other duties as assigned.
Requirements
- Good work ethic and positive attitude.
- Exceptional attention to detail.
- Able to work independently or with a team.
- Able to follow and understand quality management objectives and manufacturing procedures.
- Must be fluent in English for communicating and reading safety instructions, procedures, and customer orders and parts.
- Ability to review and understand QMS procedures, protocols and instructions.
- Able to read and interpret drawings and build sheets.
- Must be able to stand for long periods and walk continuously through assigned areas.
- Must have full range of motion.
- Must be able to wear facial mask and gowning equipment including booties, gowns/jackets, gloves, eye protection when applicable, hair net, and facial hair net if/when applicable.
- Must be able to lift 40lbs occasionally and 25lbs regularly.
- Minimum of 2 years of experience.
Nice To Haves
- Bachelor’s degree preferred.
- Experience with ISO 13485, quality systems and auditing preferred.
- Knowledge of Microsoft Suite preferred
Responsibilities
- Follow quality rules for proper gowning, cleaning, or other tasks.
- Assist with operational projects and assignments.
- Provide support on regulatory inspections, audits, investigations, and inquiries regarding the control, assessment, risk management and corrective and preventive actions of manufacturing quality.
- Collaborate with manufacturing and engineering departments to review processes for new and existing procedures, validations, inspections, and training.
- Collaborate with tool engineering department to verify tooling check in, tagging, and tool identification.
- Prepare documentation to enhance consistency throughout the manufacturing process and identify areas of improvement.
- Develop, maintain and implement quality procedures.
- Perform environmental monitoring including cleanroom testing.
- Monitor pest control program.
- Maintain database entries and records.
- Support CAPA program and provide follow-up to ensure corrective measures are taken.
- Collaborate with service vendors to ensure calibration cycles are maintained and calibrations are performed. Conduct internal calibrations as needed.
- Participate as an internal auditor.
- Perform other duties as assigned.
Benefits
- Health Insurance
- Dental Insurance
- 401(k)
- Paid time off
- Educational Reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
