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Full-timeDescription
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Position: Quality Control InspectorReports to: Director of QualityLocation: Norcross, GA (on-site)We are seeking a detail-oriented and experienced Quality Control (QC) Inspector to join our team in Norcross, Georgia. The QC Inspector will be responsible for performing CM (Component Manufacturing) inspections, product documentation, ensuring compliance, and performing a variety of inspections to maintain the highest quality standards for our medical devices.
Mission: To be a trusted partner who drives better business results for our healthcare customers. Together we grow.
Position Summary:
The Quality Control Inspector assists in maintaining the Quality Management system of GlobalMed Logistix, a leader in medical device distribution. Daily tasks would include but are not limited to QMS oversight, record review, and SOP implementation. Works closely with Operation Managers and Quality Director 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:
- Responsible for performing accurate component product inspections. Responsible for maintaining inspection documentation, including scanning and filing completed records.
- Responsible for initiating non-conformance reports and ensuring non-conforming material is processed in accordance with the disposition. May assist with nonconformance investigations as needed.
- Ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ISO, and FDA requirements.
- Responsible for maintaining the QC inspection areas. Area should be tidy, free from debris and organized. Product should be placed in bins and on racks, and not stored on the floor. Excess papers will not be stored in the inspection areas.
- Ability to utilize basic math skills to compute rates, ratios, and percentages; interpret bar graphs and charts; and perform accurate counts.
- Experience using a variety of inspection equipment with accuracy and repeatability.
- Proficiency with MS Office applications at an intermediate level or higher. Entering data into SAP. MasterControl experience a plus.
- Must work well with other employees and convey positive attitude.
Requirements
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.
This position is located in Norcross, GA, on-site essential.
