Quality Assurance Technician

Job Summary:

The candidate will work with various departments to support new and/or current product lines and processes. Typical assignments may include projects of general complexity within planned schedules/timelines, supporting audits, trending and reporting on product data, participating on teams, ensuring documentation compliance, processing complaints, CAPAs, change control, and deviations. Routine interaction with other functional areas such as Operations and Design Engineering will be required.

More specifically, the Quality Assurance Technician is primarily responsible for:

• Creating Non-conforming material reports for material disposition
• Conducting and documenting failure investigations
• Performing QC testing
• Assuring documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines
• Processing Engineering Change Notices in ERP system
• Assisting in Document Control and Training System activities
• Performing In-house calibration of measurement equipment
• Managing outside calibration services of measurement equipment
• Reviewing device history record documentation for device release to distribution

Desired Skills and Experience:

• Ability to Access policies and procedures for guidance
• Capable of using Microsoft programs and ability to learn other systems
• Effective verbal and written communication skills
• The ability to work in teams to obtain planned results
• Must be self-motivated, organized, detail oriented and have ability to multi-task
• Associates degree or equivalent experience in medical device manufacturing

Compensation and Benefits:

Compensation is commensurate with education, skills, knowledge, and experience. This position is eligible for a discretionary bonus in addition to a comprehensive benefits package.

Job Type: Full-time

Pay: $20.00 - $23.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance

Experience level:

• 1 year

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Overtime

Work setting:

• In-person
• Manufacturing facility
• Office

Ability to Relocate:

• Haw River, NC 27258: Relocate before starting work (Required)

Work Location: In person