A RECRUITMENT SOLUTIONS COMPANY (800) 594-7036

Certified Quality Auditor

- Deerfield Beach, FL, United States

City: 
 Deerfield Beach
State: 
 FL
Country: 
 United States

SHL Group

We have an immediate opening for a Certified Quality Auditor (Pharmaceutical industry) at our Deerfield Beach, Florida headquarters.

 

Our company provides final assembly, labeling and packaging services of drug delivery devices to the pharmaceutical and biotechnology industries and soon clinical fill finish capabilities. Scientist and Engineers work closely with our partners to continuously create and introduce innovative, patient centric, solutions to enhance patient compliance and user experiences. Dedicated project managers work closely with their counterparts at the partner company to develop and maintain program timelines in line with the strategic and business needs of our partners. In addition, for those partners who wish to have SHL handle the final assembly process, SHL Pharma offers robust final assembly and labeling capabilities that enable our partners to improve speed to market and reduce the number of parties involved as well as have one clear point of responsibility.

 

Job description:

The main job of a Quality Auditor is to assist in the implementation of effective quality systems and achievement of Quality Objectives by coordinating, performing, and improving all Internal and External Audit activities. Some of these activities included but are not limited to:

 

  • Owning and managing the Internal and External Audit Procedures
  • Preparing and executing the Annual Internal Audit Schedule
  • Preparing the Supplier Audit Schedule
  • Coordinating Supplier audits
  • Participating in Audits as the Lead Auditor
  • Coordinating and hosting Customer and Regulatory Agencies audits (FDA, ISO, etc.)
  • Preparing Audit Reports
  • Reviewing Audit Responses
  • Coordinating Corrective Action implementation through the NCR and CAPA systems
  • Assists with training activities for different departments
  • Initiating internal communication regarding audit results and improvements
  • Presenting Audit results and improvements during Management Reviews
  • Evaluate and approve new and current suppliers 
  • Contribute to the development and improvement of audit program metrics.

Requirements:

  • Four year degree in a related field or a minimum of 5 years’ experience in Quality Auditing in a Medical Device or Pharmaceutical industry.
  • Significant work experience in Quality System Auditing (ASQ certification or ISO Lead Audit certification is preferred).
  • Knowledge of national and international regulations applicable to medical devices including: FDA 21CFR Part 820(QSR), FDA 21CFR Part 210, 211, ISO 13485, MDD (European) requirements, etc.
  • Key Leadership Skill include management level person, organization and people development, negotiating and influencing positive change in organizations, effective presentation and communication skills.

 

Ability to analyze situations thoroughly, identify potential problems, find and implement effective solutions.

We have an excellent benefits package and offer a salary that is based on experience and accomplishments.

If you possess the required experience and qualifications and want the challenge of growing with our company then submit your resume in confidence to our Human Resources Department at SHL@SelfOpportunity.com.


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P.O.Box 292788 Lewisville, TX 75029-2788  |  Phones: (214) 222-1500  |  (214) 222-8884  |  (800) 594-7036

P.O.Box 292788
Lewisville, TX
75029-2788

Phones:
  (214) 222-1500
  (214) 222-8884
  (800) 594-7036

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