SUMMARY:
Under the direct supervision of the Quality Manager, the Quality Coordinator ensures that all documents and training meet QMS requirements. The Quality Coordinator will manage inspection criteria and calibration of inspection tools in order to ensure product verification. Auditing of processes and ECO projects will enable effective continual improvement and proper communication of changes to all stakeholders.
RESPONSIBILITIES:
- Leads in the organization, maintenance, review and reporting of our Document Control System.
- Collects, files and maintains specifications and documents for product data control.
- Manages inspection criteria and reporting in QMS software.
- Conducts or assists with regulatory and quality training sessions.
- Maintains Training module in QMS software as well as training procedure and records.
- Collaborates with business process owners to assist with training content development and deployment.
- Manages calibration and verification activities for all tools used in inspection, manufacturing verification, and product testing.
- Performs configuration control audit to ensure Engineering Change Orders (ECO's) have been fully implemented.
- Manages the collection and organization of monthly KPI reports of activities, processes, and procedures that affect CMC's quality and regulatory compliance.
- Conducts internal audits and reports findings.
- Manages the Approved Sample process.
- Supports regulatory certification activities including site audits.
- Ensures proper documentation for process changes in the QMS system.
- Performs manufacturing inspections and reviews to ensure employees adhere to quality and safety policies.
- Provides departments with quality support.
- Maintain regular and punctual attendance.
- Comply with all company policies and procedures.
- Other duties assigned as necessary.
KNOWLEDGE, SKILLS AND ABILITIES:
- Ability to read and interpret general business forms and government documents
- Ability to perform mathematical computations such as percentages, fractions, addition, subtraction, multiplication and division
- Must possess strong communication skills to effectively present information and respond to questions from management, customers, and colleagues in both verbal and written form.
- Intermediate Excel skills
- Proven ability to lead cross-functional projects from many departments.
- Strategic thinker with strong analytical ability and problem-solving skills.
- Strong organizational skills with the ability to manage multiple activities simultaneously.
QUALIFICATIONS (Education and experience)
- 4+ years of quality systems experience
- A Bachelor's degree in Operations, Quality Assurance or related field preferred
- Experience with ISO-9001:2015 preferred
- Familiarity with international regulatory requirements (NFPA, CE, ANSI, ASTM, FDA, U/L and their international equivalents)
- Experience with Epicor (ERP) is a plus.
- certification in Six Sigma, Kaizen, Lean, cGMP or other operations methodology is a plus.
- Bi-lingual (English and Spanish) strongly preferred.
- Manufacturing experience is a plus
ESSENTIAL FUNCTIONS
Working conditions are in a normal office environment. While performing the duties of this job, the employee is regularly required to walk; sit and stand; using the hands to handle, finger, or feel objects, tools, or controls. Occasionally, the employee must crouch or kneel. The employee must occasionally exert or lift up to 20 pounds. Successful performance requires good eyesight with or without corrective lens. Requires long periods of time working at a computer and includes phone work.
DISCLAIMER
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification and may be amended at any time at the sole discretion of the Employer. It is not designed to contain or be interpreted as comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.
Compensation details: 29-33 Hourly Wage
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