QMS Specialist

Company Description

DEPARTMENT:  Quality/Regulatory

POSITION REPORTS TO:  ISO Coordinator/ QA Manager

Job Purpose/Summary Statement:

Works closely with the department mangers in problem-solving, issues, regulatory affairs etc.  Trains new and existing personnel, on OSHA and FDA guidelines and the ISO quality management system. Maintains the quality management system and is the quality management representative in Texas facility. Plans and conducts new employee orientation as it relates to QMS and to foster positive attitude toward company goals.  Employment is at-will and this Job Description does not constitute a contract of employment.

Qualifications:

• Bachelor’s degree or three years of experience.
• Previous experience in QMS, ISO,  regulatory affairs desired.

• Ability to communicate verbally and in writing in a professional manner at all levels within the company and represent the company in a positive manner.
• Highly developed organizational skills with attention to detail
• Self motivated, high energy level
• Persistence and initiative
• Problem solving techniques
• Ability to conceptualize the interactions of processes with regards to integrating for a effective and efficient quality system as it relates to the organizations goals
• Ability to treat confidential information with sensitivity.
• Must be assertive, objective, and participative, and able to work with people at all levels.
• Must be flexible with schedule and periodically work long hours; some evenings and weekends.  Some travel required.  (Although the company policy is to provide the safest possible work environment for all its employees, there is a minimal amount of risk with this level of responsibility).
• Commitment to Quality

Essential Functions:

• Maintaining and updating Quality Management Systems within the document control system , Master Control.
• Organizing, documenting and communicating to responsible parties
• Must work with all aspects of regulatory affairs (FDA, OSHA, others as applicable) and help the organization make appropriate decisions in regards to regulatory affairs be official correspondent.
• Must have strong leadership skills with the ability to drive the continual improvement process within the organization.
• Expected to support the goals, objectives, policies, and leadership of the organization, and participate in the continuous improvement effort of all areas and self.
• Will be responsible for assisting in training of new and existing employees on changes in QMS processes, procedures or work instructions and documentation of the training provided.
• Will be responsible for assisting in the coordination of internal and external audits, functioning as an internal auditor as necessary.
• Will be responsible for assisting in coordinating corrective/preventive actions, customer complaints and non-conformances and investigating root cause and effectiveness of actions taken.
• Maintain accurate and complete personnel training records as it relates to the QMS.  Ensures that rules concerning confidentiality and retention are followed.
• Performs other incidental and related duties as required or as requested by management.

Authority:

1. Identify nonconforming products/services per procedures. 
2. Generate NCR’s identifying Preventive/Corrective action to process or product.
3. To override judgments of inspectors in the best interest of the customer.
4. Affect any change(s) necessary to maintain applicable certifications/registration.

Additional Information

All your information will be kept confidential according to EEOC guidelines.