QA Specialist I - CAPA & Quality Impact

Millstone Medical; Olive Branch, Northern (MS, KY); Hybrid; USD 52,000 - 76,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Supplemental benefits

Paid time off

Tuition reimbursement

Career pathing

401(k) with match

Job summary

Millstone Medical is seeking a QA Specialist to drive CAPA activities and support QA across multiple sites. The role emphasizes root-cause analysis, corrective action implementation, and collaboration within a team to uphold ISO and FDA/GMP standards.

We offer a comprehensive Total Rewards Benefits Program, including medical, dental, vision, life, disability, and tuition reimbursement, along with PTO and 401(k) with match.

Qualifications

• Bachelor’s Degree with 3–5 years of QA experience in a medical device environment.
• Inspection and Mechanical Aptitude using gauges/calipers and color charts.
• Calibrate with workmanship expectations of customer.
• Recognize and communicate potential issues.
• High attention to detail and teamwork required.
• Proficient in Excel, PowerPoint & Word with macros.

Responsibilities

• Investigate root causes and develop corrective actions across sites.
• Participate in internal and external audits.
• Perform special projects within the Quality department.

Skills

Quality experience

Inspection aptitude

Root cause analysis

Attention to detail

Team collaboration

Training others

Problem solving

FDA/GMP knowledge

Reading procedures in English

Communication skills

Education

Bachelor’s degree in QA/medical devices

Tools

Excel

PowerPoint

Word

Job description

Millstone Medical is seeking a QA Specialist to drive CAPA activities and support QA across multiple sites. The role emphasizes root-cause analysis, corrective action implementation, and collaboration within a team to uphold ISO and FDA/GMP standards.

We offer a comprehensive Total Rewards Benefits Program, including medical, dental, vision, life, disability, and tuition reimbursement, along with PTO and 401(k) with match.