Quality Specialist

GlobalMed Logistix; Norcross (GA); On-site; USD 50,000 - 55,000; Full time

Job summary

A leading company in medical device distribution seeks a Quality Specialist I. The role encompasses maintaining the Quality Management System and ensuring compliance with FDA regulations. Ideal candidates should possess a Bachelor's degree and at least one year of Quality experience. You will thrive in a dynamic environment, contributing to quality assurance processes critical for the industry.

Qualifications

• Minimum 1 year experience in Quality (ISO 9001 and 13485).
• Experience in a regulated industry preferred.
• Legal authorization to work in the U.S.

Responsibilities

• Ensure the QMS system is updated and implemented.
• Review and investigate nonconformance reports.
• Collaborate with team members for NCR investigations.

Skills

Attention to detail

Communication

Problem Solving

Teamwork

Education

Bachelor’s Degree in Business, Supply Chain, Life Sciences, or related field

Tools

Microsoft Office

Job description

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Location: Norcross, GA (on-site)

Position: Quality Specialist I

Location: Norcross, GA (on-site)

Mission: To be a trusted partner who drives better business results for our healthcare customers. Together we grow.

Position Summary

The Quality Specialist assists in maintaining the Quality Management System of GlobalMed Logistix, a leader in medical device distribution. Daily tasks include investigating nonconformances (NCRs), overseeing QMS, reviewing records, scanning and filing training records, and verifying training completion. Works closely with Operation Managers and the Quality Manager to ensure compliance with all FDA/Federal regulations and internal standards. Maintains a rigorous quality mindset and advocates strict adherence to compliance practices within the facility. Possesses skills in the medical device industry and current Good Manufacturing Practice (GMP) requirements for storage, CBP process, international shipping, and domestic shipping.

Scope Of Role Responsibilities

• Ensure the QMS system is updated, implemented, and followed by all employees.
• Scan records and file in SharePoint.
• Review nonconformance reports, investigate, add objective evidence, and route for closure.
• Verify nonconforming goods are placed in the NCR room daily and match quantities and reports.
• Collaborate with team members to gather missing information for NCR investigations.
• Review purchase orders, maintain PO Log, and inspect received products.
• Update training logs and assist in documenting and scanning records.
• Review records related to human tissue processing and medical device production.
• Understand ISO requirements, GTPs, and Quality System Regulations relevant to operations.
• Develop and monitor operational and performance metrics.
• Contribute to the documentation process for policies, procedures, and forms.
• Optimize processes to increase productivity and revenues.
• Coordinate with managers on project planning and QMS procedures.
• Identify SOPs and regulatory documents needing improvement or development.
• Keep staff informed about policies and procedures, fostering cooperation.
• Respond promptly and courteously to internal and external inquiries.
• Perform other tasks as assigned by quality management.

Critical Experience & Skills

• Bachelor’s Degree in Business, Supply Chain, Life Sciences, or related field, or equivalent experience.
• Minimum 1 year experience in Quality (ISO 9001 and 13485).
• Experience in a regulated industry preferred.
• Ability to work in a matrix environment.
• Proficient in Microsoft Office.
• Experience in a fast-paced, growing environment.
• Excellent verbal and written communication skills.
• Ability to lift up to 50 pounds.
• Legal authorization to work in the U.S.
• Willing to undergo background check and drug screening.
• Must be at least 18 years old.

Required Competencies

• Accuracy/Quality: Attention to detail, commitment to excellence, continuous improvement.
• Adaptability/Flexibility: Open to change, handles pressure well.
• Dealing with Ambiguity: Manages risk and uncertainty effectively.
• Dependability: Reliable, accountable, punctual.
• Innovation: Creative problem-solving.
• Integrity/Ethics: Honest, maintains confidentiality.
• Organization: Manages multiple tasks efficiently.
• Problem Solving: Data interpretation and solution development.
• Sense of Urgency: Decisive and proactive.
• Teamwork: Collaborates effectively with others.

Physical Demands

Regularly required to stand, walk, handle objects, reach, stoop, kneel, crouch, sit, climb, balance, and lift/move up to 50 pounds. Must navigate the warehouse physically.

Employment Type: Full Time

Years Experience: 1 - 3 years

Salary: $50,000 - $55,000 annually

Bonus/Commission: Yes

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Quality Assurance and Manufacturing

Industries

• Transportation, Logistics, Supply Chain, Storage