QA Specialist I

Millstone Medical • Olive Branch, MS

6h

About The Position

The QA Specialist I primarily facilitates Millstone Medical’s CAPA system. The role works within a team across multiple sites to investigate issues, determine root causes, and develop and implement corrective actions. It also participates in internal and external audits and performs special projects as needed within the Quality department.

Millstone Medical is a medical service provider focused on sterile and non-sterile packaging of medical devices, as well as mechanical inspection and assembly. The company is FDA and ISO registered and maintains an internal quality system to support ISO compliance.

Requirements

• Bachelor’s degree and 3–5 years of Quality experience; experience in a medical device environment is preferred.
• Inspection and mechanical aptitude, including use of scales, gauges, calipers, Tappi, and color charts.
• Calibrate according to customer workmanship expectations.
• Recognize and communicate potential issues.
• High attention to detail and ability to work in a team environment.
• Basic addition and subtraction; advanced skills in algebra, trigonometry, and statistics.
• Basic software and computer skills.
• Advanced ability to create Microsoft Excel, PowerPoint, and Word documents, including incorporating functions and writing macros.
• Ability to read and follow department procedures in English.
• Ability to review procedures for correctness and write or rewrite procedures and check sheets.
• Ability to define system-wide objectives.
• Excellent interpersonal and customer service skills; ability to work with internal customers at various organizational levels.
• Ability to train others, including training the trainer.
• Ability to work independently to solve daily issues and problems.
• Understanding of workflow and daily requirements.
• Knowledge and execution of issues related to FDA/GMP compliance.
• Understanding of GD&T.
• Excellent organizational skills.

Nice To Haves

• Quality experience in a medical device environment.

Responsibilities

• Facilitate Millstone’s CAPA system.
• Work across multiple sites with a team to investigate issues, determine root causes, and develop and implement corrective actions.
• Participate in internal and external audits.
• Perform special projects as needed within the Quality department.

Benefits

• Medical insurance starting on the first day of employment
• Dental insurance starting on the first day of employment
• Vision insurance starting on the first day of employment
• Supplemental benefits, including life, disability, and critical illness coverage
• Paid time off
• Tuition reimbursement
• Career pathing
• 401(k) with match
• Competitive compensation

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level