QA Specialist I

Socket.dev; Sibley (MS); On-site; USD 60,000 - 90,000; Full time

Job summary

Millstone Medical is seeking a QA Specialist to drive CAPA processes and support quality systems across multiple sites. You will investigate root causes, develop corrective actions, and support audits to ensure ISO/FDA compliance.

Ideal candidates have a Bachelor’s in Quality/Engineering with 3–5 years in medical device QA, strong documentation skills, and proficiency in Excel macros. On-site position offering comprehensive benefits.

Qualifications

• Bachelor’s Degree with 3-5 years of quality experience in medical device environment.
• Experience inspecting via scales/gauges/calipers and color charts.
• Knowledge of FDA/GMP and ISO requirements.
• Understanding of GD&T and ability to read and follow procedures in English.
• Ability to train others and work independently.

Responsibilities

• Facilitate Millstone’s CAPA system across sites; investigate root causes and implement corrective actions.
• Participate in internal and external audits.
• Perform special QA projects as needed within the department.

Skills

Root cause analysis

CAPA systems

Attention to detail

GMP compliance

GD&T

Team collaboration

Excel/macros

English procedures

Education

Bachelor’s Degree in Quality/Engineering

Tools

Microsoft Excel

PowerPoint

Word

Job description

Come join Millstone Medical and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work!

Millstone is a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry. Millstone’s business focus is sterile and non-sterile packaging of medical devices.

Millstone also engages in other activities, such as mechanical inspection and assembly, which are designed to meet the outsourcing requirements of medical device manufacturers seeking to reduce costs while maintaining high levels of quality, accuracy, and timeliness. We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO compliance.

What's in it for you?

A company committed to quality, growth, career pathing.

At Millstone, we want you to be your best at work and at home. In addition to competitive compensation, we have designed our Total Rewards Benefits Program to support the physical and emotional well-being of our employees and their families.

Total Rewards Benefits Program:

• Medical - Starting on the 1st day of employment
• Dental - Starting on the 1st day of employment
• Vision - Starting on the 1st day of employment
• Supplemental Benefits - Life, Disability, Critical Illness
• Paid Time Off
• Tuition Reimbursement
• Career Pathing
• 401(k) with match

The QA Specialist is primarily responsible for facilitating Millstone’s CAPA system. Additional responsibilities include:

• Working within a team environment across multiple sites to investigate, determine root cause, and develop and implement corrective actions.
• Participate in internal and external audits.
• Perform special projects as needed within the Quality department

Knowledge & Skills:

• Bachelor’s Degree with at least 3-5 years of Quality experience preferably in a medical device environment.
• Inspection and Mechanical Aptitude using scales/gauges/calipers/Tappi and color charts
• Calibrate with workmanship expectations of customer
• Recognize and communicate potential issues
• High attention to detail and the ability to work in a team environment are essential
• Basic addition/subtraction; advanced skills in algebra, trigonometry, and statistics
• Basic knowledge of software & computer skills
• Advanced ability to create Microsoft Excel, PowerPoint & Word documents with expert ability to incorporate functions & write macros. Ability to incorporate functions and write macros
• Ability to read and follow all department procedures in English
• Ability to review procedures for correctness
• Ability to write or re-write procedures and check sheets
• Ability to define system wide objectives
• Excellent interpersonal and customer service skills
• Works well with internal customers from various levels of the organization
• Capacity to train others, including “training the trainer”
• Working independently to solve daily issues/problems
• Understands workflow or daily requirements
• Knowledge and execution of issues related to FDA/GMP compliance
• Understanding of GD&T
• Excellent organizational skills

To learn more about Millstone Medical, please visit us online at www.millstonemedical.com.

ADDITIONAL INFORMATION:

Millstone Medical Outsourcing provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status, or any other status protected by applicable federal, state, or local law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.