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17 days ago
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Senior Quality Systems Engineers


STS Aviation Group
Location: Salt Lake City, Utah
Job type: Contract/Locum
Contact: No Name
Category: Engineers
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Job Summary:

The Sr. Quality Systems Engineer is responsible for assuring compliance with FDA/GMP/QSR and ISO 13485 commitments on products sold globally. This job is critical as failure to identify and recommend corrective actions could result in legal enforcement action, critical delays in schedules and/or departmental operations and may jeopardize overall business activities.

Job Duties:

  • Ownership of the CAPA system
  • Coordinating with technical staff directed to closing CAPAs
  • Communication of CAPA status to executive management
  • Management of customer issued Supplier Corrective Action Reports
  • Communication to customers of status of SCARs
  • Management and completion of Internal Audits, including managing the schedule, completing the audits, writing the audit report and closing any non-conformities issued
  • Lead continuous improvement of Quality Systems, such as CAPA and Internal Audits, and direct the efforts to develop, implement and maintain compliant and effective Quality Systems
  • Lead cross-functional teams to complete projects, address quality issues and implement quality system improvements
  • Identify compliance gaps and lead focused teams to resolve compliance issues
  • Support the promotion, socialization, development and implementation of Corrective and Preventative Action system
  • Coordinate and review progress and accuracy of assigned tasks with cross-departmental team members
  • Lead and manage the site Corrective Action Board
  • Lead by example to foster a commitment to quality in personnel, and a culture of quality within the organization
  • Interact and influence peers to ensure successful project completion
  • Maintain current knowledge of Compliance program and of applicable company standard operating procedures for areas of responsibility
  • Provide guidance on interpretation and application of specified QA compliance regulations
  • Lead internal audit program
  • Complete required training in a timely manner
  • Other projects as assigned by a member of client management

Qualifications:

  • Bachelor’s degree from an accredited University
  • 2+ years’ experience in a regulated industry
  • Strong interpersonal and communication skills
  • Demonstrated in-depth knowledge of Good Manufacturing Practices (GMPs), QA systems principles, concepts, industry practices, and standards
  • Demonstrates excellent verbal, written, and interpersonal communication skills with all levels of staff and both internal and external customers
  • Keen understanding of international quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives
  • Demonstrated experience as a change agent in driving complex change, understanding the cultural dynamics of the current state of an organization, creating a strategic practical course, balancing the current reality with the need for rapid adoption of the desired future reality which then generates change with a high degree of transformation
  • Experience with managing key Quality Management System processes such as CAPA, Internal Audits and Management Review
  • Understanding of current global regulatory expectations, such as 21CFR Parts 820 and ISO 13485
  • ISO 13485 Lead Auditor Certified
  • Significant experience with quality systems in a Medical device environment required
  • Excellent organization skills and ability to work on a number of projects simultaneously to tight timelines
  • Demonstrated leadership skills
  • Excellent attention to detail, and ability to consistently meet high standards of quality required in QA Compliance
  • Proficient with the Microsoft Word, Excel, PowerPoint and Outlook
  • Able to succeed in a highly regulated environment while still providing service excellence

Benefits:

STS AeroStaff Services offers direct deposits / electric payroll, an awesome medical insurance program, cash advances and the opportunity to refer a friend for compensation.

We know it takes great people to do great work, and if you’re interested in joining the STS Aviation Group family, we encourage you to apply on this page. 

Job Summary:

The Sr. Quality Systems Engineer is responsible for assuring compliance with FDA/GMP/QSR and ISO 13485 commitments on products sold globally. This job is critical as failure to identify and recommend corrective actions could result in legal enforcement action, critical delays in schedules and/or departmental operations and may jeopardize overall business activities.

Job Duties:

  • Ownership of the CAPA system
  • Coordinating with technical staff directed to closing CAPAs
  • Communication of CAPA status to executive management
  • Management of customer issued Supplier Corrective Action Reports
  • Communication to customers of status of SCARs
  • Management and completion of Internal Audits, including managing the schedule, completing the audits, writing the audit report and closing any non-conformities issued
  • Lead continuous improvement of Quality Systems, such as CAPA and Internal Audits, and direct the efforts to develop, implement and maintain compliant and effective Quality Systems
  • Lead cross-functional teams to complete projects, address quality issues and implement quality system improvements
  • Identify compliance gaps and lead focused teams to resolve compliance issues
  • Support the promotion, socialization, development and implementation of Corrective and Preventative Action system
  • Coordinate and review progress and accuracy of assigned tasks with cross-departmental team members
  • Lead and manage the site Corrective Action Board
  • Lead by example to foster a commitment to quality in personnel, and a culture of quality within the organization
  • Interact and influence peers to ensure successful project completion
  • Maintain current knowledge of Compliance program and of applicable company standard operating procedures for areas of responsibility
  • Provide guidance on interpretation and application of specified QA compliance regulations
  • Lead internal audit program
  • Complete required training in a timely manner
  • Other projects as assigned by a member of client management

Qualifications:

  • Bachelor’s degree from an accredited University
  • 2+ years’ experience in a regulated industry
  • Strong interpersonal and communication skills
  • Demonstrated in-depth knowledge of Good Manufacturing Practices (GMPs), QA systems principles, concepts, industry practices, and standards
  • Demonstrates excellent verbal, written, and interpersonal communication skills with all levels of staff and both internal and external customers
  • Keen understanding of international quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives
  • Demonstrated experience as a change agent in driving complex change, understanding the cultural dynamics of the current state of an organization, creating a strategic practical course, balancing the current reality with the need for rapid adoption of the desired future reality which then generates change with a high degree of transformation
  • Experience with managing key Quality Management System processes such as CAPA, Internal Audits and Management Review
  • Understanding of current global regulatory expectations, such as 21CFR Parts 820 and ISO 13485
  • ISO 13485 Lead Auditor Certified
  • Significant experience with quality systems in a Medical device environment required
  • Excellent organization skills and ability to work on a number of projects simultaneously to tight timelines
  • Demonstrated leadership skills
  • Excellent attention to detail, and ability to consistently meet high standards of quality required in QA Compliance
  • Proficient with the Microsoft Word, Excel, PowerPoint and Outlook
  • Able to succeed in a highly regulated environment while still providing service excellence

Benefits:

STS AeroStaff Services offers direct deposits / electric payroll, an awesome medical insurance program, cash advances and the opportunity to refer a friend for compensation.

We know it takes great people to do great work, and if you’re interested in joining the STS Aviation Group family, we encourage you to apply on this page. 

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