Quality Auditing Specialist

Role Purpose

This role will support the division quality auditing team to ensure quality system compliance with applicable ISO and regulatory requirements. This role is responsible for completing audit related activities such as acting as an internal auditor, managing auditor qualification records, and reviewing supplier assessments. This role will interface with internal and external customers to process audit requests and ensure auditing requirements are met on time.

Key Responsibilities

• Work with Global Supply Management (GSM), division quality, and plant quality teams to support division supplier quality management requirements.
• Maintain and update division approved supplier list and the supplier audit system.
• Support supplier assessment activities such as completing supplier questionaries, reviewing supplier qualification records, and participating as an auditor during supplier audits.
• Gathers internal/external audit related performance data from all CLS sites. Analyzes data and prepares data summaries of performance metrics.
• Participates as an auditor for the internal audit program. Works with sites to complete internal audit pre-work documentation.
• Assembles auditor qualification records.
• Processes customer audit requests, assist customers to fulfill their supplier management requirements. Works cross-functionally to process requests for NDAs and quality agreements. Escalates customer issues immediately.
• Affords assistance to manage supplier, internal audit, and customer audit schedules.
• Initiates Change Controls and Document Change Requests to update audit related procedures and processes. Collaborates with manufacturing and distribution sites to assess impact of changes to site level processes.
• Supports various projects, including new product/process, cost reduction and quality improvement efforts.

Experiences/Education - Required

• Bachelor’s degree in engineering, life sciences, or a related technical discipline
• 3-5 years of experience working in an ISO certified environment such as ISO 9001 (experience working in an ISO 13485 manufacturing environment is preferred).
• Proficient with Microsoft Office Applications
• Must be detail oriented and accurate
• Effectively, positively & professionally interact with internal and external customers
• Ability to apply basic mathematical concepts such as percentages, ratios, and proportions to practical situations.
• Previous experience working in an electronic quality management system software preferred (such as ETQ or Trackwise)

Travel requirements

50%

Pay Range

$80,001.00 - $110,001.00 assuming full time status. Starting pay for the successful applicant is dependent on a variety of job-related factors, including but not limited to geographic location, market demands, experience, training, and education.