Job Description

Reporting to the Site Quality Manager, the Quality Coordinator is responsible for ensuring that the organization conforms to regulatory requirements, as well as, examining products and materials for defects or deviations from specifications of the Quality Management System (QMS). This is a highly visible position that will require attention to detail and the ability to communicate effectively with all levels of employees across the company.

This position is on 1st shift - must be available to work 8 hour shifts and 10 hour shifts, as needed.

Essential Job Functions

• Determines schedules, priorities, and assigns tasks/resources
• Train employees and contractors on company policies; production procedures and forms; and the use of new equipment, as appropriate
• Develop training plans for new employees
• Maintain training records of all employees
• Read product and package specification drawings
• Responsible for writing and/or assisting in the writing of Quality procedures
• Helps to perform root cause analysis and corrective actions for quality related issues
• Generates device history file (batch record file)
• Accepts or rejects finished items
• Completes non-conformances on products and materials that fail to meet specifications
• Maintain calibrations and preventive maintenance systems
• Review proofs of artwork prior to literature being printed for production
• Involved with all aspects of the work order process
• Change control in MasterControl
• Create UDI labels for new products and update current labels according to any changes needed
• Maintains quality service by establishing and enforcing organization standards
• Perform duties as back-up to the Quality Inspectors
• Completes certificates for finished goods per customer requirements
• Oversee returns from customers
• Other duties as assigned

Requirements

Qualifications

• Undergraduate diploma and minimum two (2) years of experience working in medical device manufacturing or related field in a team environment
• One (1+) year(s) in a Quality Control or Quality Assurance position with a medical device manufacturer or related field
• Working knowledge of cGMP and cGDP, as well as FDA and ISO standards is a plus
• Knowledge of testing equipment, statistical methods, and control plans
• Computer skills including Microsoft Word, Excel, and Powerpoint
• Knowledge of ERP systems (e.g., Microsoft 365, SAP, etc.)
• Able to work well independently and detailed oriented
• Strong interpersonal skills with the ability to deal effectively, and respectfully, with a variety of personnel
• Able to read and interpret documents such as safety rules, standard operating procedures (SOPs), work process aids, company policies, and instruction manuals
• Able to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Able to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form
• Able to compute rate, ratio, and percent
• Able to operate a pallet jack

Supervisory Responsibilities

The Quality Coordinator may have to perform supervisory responsibilities at times, in accordance with the organization’s policies and applicable laws. Responsibilities may include interviewing and training employees, planning, assigning, and directing work.

Physical Requirements

Performing the duties of this job regularly involves sitting, standing, walking, hearing/listening, repetitive hand movement, grasping, reaching, lifting, carrying, bending/stooping, kneeling/crawling, climbing, balancing, pushing/pulling, vision requirements - close vision.

Mental Requirements

This position requires the ability to maintain an appropriate work pace, comprehend and follow instructions, exercise logic and reasoning, organize and prioritize, read, compose written communication, communicate verbally, problem solve, count, and compute, and multi-task/re-direct. This position requires the ability to maintain the highest standards of professional maturity and emotional intelligence even in difficult or stressful situations.

Other Requirements

The employee must be trained on all the documents, procedures, software applications and topics listed in the Training Matrix. Documentation of this training will be maintained with Human Resources. Additional training requirements may be added as deemed necessary by the supervisor.

Work Environment

The noise level in the work environment is usually quiet to moderate.