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Title

Quality and Regulatory Manager 

Category Safety/CI & Quality & Regulatory  
Description

JOB DESCRIPTION

POSITION TITLE: Quality and Regulatory Manager

TEAM: Quality

BASIC FUNCTION:

Under the direction of, and reporting to the Director of Operations, the Quality and Regulatory Manager is responsible for the development, implementation and maintance of organization's Quality Management System (QMS). Additional responsibility for ensuring compliance of all customer and regulatory agencies standards.

KEY RESPONSIBILITIES:

  1. Manage the customer's quality expectations and establish company standards for finished products by devising evaluation tests, and creating methods and procedures, to ensure a superior quality product.

  2. Maintain a Quality Management System using the Food & Drug Administration (FDA), Good Manufacturing Practices (GMP) standards.

  3. Collaborate with Supply Chain and Product Development to maintain raw material standards and vendor performance.

  4. Manage the monitoring, measurement, and review of internal processes, especially those that affect the quality of the organization's products.

  5. Facilitate customer audits, conduct tours, address non-compliance issues, and implement corrective action.

  6. Oversee customer complaint system, to include root cause analysis and corrective action response to the customer.

  7. Responsible for updating the Quality Manual, as well as, maintaining requires quality assurance programs and quality control policies.

  8. Oversee compliance for applicable regulatory agency standards, as well as, applicable certification standards.

  9. Instruct, guide and administer to employee needs in the performance of their work.

  10. Responsible for establishing team policies/procedures connected to company objectives.

  11. Oversee product recall.

  12. Conduct annual senior management review meeting and report on performance of the QMS (e.g., results of quality audits, corrective actions, etc.) including the opportunties for improvment.

  13. Keep up on standards, regulations/laws, issues and news with respect to product (service) quality.

  14. Perform other duties as assigned.

 
Position Requirements

KNOWLEDGE, SKILLS AND ABILITIES:
Strong leadership skills and the ability to take initiative

An effective working knowledge of Quality Management System (QMS)

Ability to lead and manage teams and projects and to handle project through to completion

Ability to prioritize work tasks, multi-task and maintain focus

Excellent communication skills (verbal/written) and large group presentation experience

A demostrated ability to influence change

Enthusiastic self-starter with a passion for driving quality improvements

Willingness to challenge the status quo and facilitate different perspectives to drive solutions

EDUCATION AND EXPERIENCE:
Bachelor degree in Business, Quality or equivalent education required

Minimum of 5 years of Quality management experience in a manufacturing environment

 
Full-Time/Part-Time Full-Time  
Shift Days  
Hourly The position has a bonus structure.  
Position Quality and Regulatory Manager  
Post Internal Days 0  
Number of Openings 1  
Exempt/Non-Exempt Exempt  
Hiring Manager(s)  
Req Number SAF-19-00004  
Location Menomonee Falls - Glenroy, Inc.  
EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.  

This position is currently accepting applications.

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