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 Qualiy Management system of GlobalMed Logistix, a leader in medical device distribution. Daily tasks would include but are not limited to investigating nonconformances (NCRs), QMS oversight, pulling and reviewing records, scanning and filing training records, verifying training has been completed.  Works closely with Operation Managers and Quality Manager to ensure day-to-day operations are performed to all FDA / Federal regulations and internal standards. Maintains 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) compliance requirements for storage, CBP process, international shipping, and domestic shipping, etc.  

  Scope of Role Responsibilities:

• Ensures the QMS system is updated, implemented, and adhered to by all employees of GMLx.
• Scans records and files in appropriate SharePoint locations.
• Nonconformance reports – reviews information, investigates, adds objective evidence, and routes NCR for closure.
• Verified nonconforming goods were placed in the NCR room each day and the information match the quantity and NCR report. 
• Reach out to team members to obtain any missing information regarding investigating NCRs.
• Reviews purchase orders and maintains PO Log and receipt of purchase product inspection form.
• Updates training log.
• Assists in documenting and scanning records.
• Review all records associated with the processing of human tissue and production of medical device products.
• Understand ISO requirements, GTPs, and the Quality System Regulations as they pertain to the entire operation, i.e., nonconformities, Good Documentation Practices, calibration, equipment maintenance, tissue/product storage and identification, validation, risk, etc.
• Develops and performs to Operational and Performance Metrics.
• Provide input to management that facilitates the process for new, revised, and obsoleted documents (policies, procedures, forms, templates, etc.) as they pertain to the job.
• Increase productivity and revenues by optimizing processes, work-flows, and manufacturing equipment.
• Interacts with managers to discuss project planning cross functional QMS procedures.
• Interacts with internal staff to identify SOPs and regulatory documents requiring further improvement or development.
• Keep supervisors and company personnel informed of significant information, company policies and procedures as they become available, and provide such information in a manner that encourages willing cooperation and support.
• Engage, interact and respond in a prompt, accurate, courteous and poised manner to encourage positive business relationships.
• Consistently demonstrate a positive, constructive, and cooperative attitude in the business environment.
• Effectively complete “other” functions and tasks as assigned by quality management.

Critical Experience & Skills:

• Bachelor’s Degree in Business, Supply Chain, Life Sciences or other scientific field or equivalent work experience.
• Minimum 1 year experience in Quality (ISO 9001 and 13485).
• Previous experience in a regulated industry is preferred.
• Experience working in a matrix environment in which collaboration in all directions is necessary.
• Proficient level with Microsoft Office (Outlook, Excel, PowerPoint).
• Experience working in a fast-paced rapidly growing environment.
• Excellent communication both verbal & written.
• Ability to lift up to 50 pounds.
• Must be legally authorized to work in the United States.
• Must be willing to submit to a pre-employment background check and drug screen
• Must be at least 18 years of age.

Required Competencies:

Accuracy/Quality– Is attentive to detail and accuracy. Committed to excellence, looks for improvements continuously, monitors quality levels, finds root cause of quality problems and own/acts on them.

Adaptability/Flexibility – Adapts to change, is open to new ideas, takes on new responsibilities, handles pressure and adjusts to meet changing needs.

Dealing with Ambiguity - Effectively copes with rapid change. Comfortably handles risk and uncertainty, is not easily rattled.

Dependability – Meets commitments, works independently, accepts accountability, handles change, sets personal standards, stays focused under pressure and meets attendance/punctuality requirements.

Innovation - Finds creative solutions to problems/needs that lead to positive outcomes, translates creative ideas into tangible action items.

Integrity/Ethics – Deals with others in a straightforward and honest manner, is accountable for actions, maintains confidentiality, supports company values and conveys good news and bad.

Organization – Manages multiple, simultaneous activities and projects. Organizes resources to accomplish tasks in an efficient and effective way, coordinates multiple people and functions to accomplish a single goal, prioritizes multiple activities and capitalizes on all available resources.

Problem Solving – Interprets data and gives recommendations, solves unique and challenging problems, undertakes task and breaks them down into manageable parts in a systematic way and thinks of all possible alternatives for a situation.

Sense of Urgency – Makes and executes decisions in swift and timely manner. Pursues everything with drive and preservice, often goes “above and beyond” to complete the task at hand.

Teamwork - Meets all team deadlines and responsibility, listens to others and values opinions, helps team leader to meet goals, welcomes newcomers and promotes a team atmosphere.

Physical Demands

While performing the duties of this job, the employee is regularly required to stand, walk, use hands to handle or feel, reach with hands and arms, stoop, kneel, and crouch. The employee is regularly required to sit and climb or balance and lift and/or move up to 50 pounds. The employee is regularly required to access and physically navigate the warehouse facility.