Quality Systems Manager

Brasseler USA - Savannah, GA4.1

Full-timeEstimated: $78,000 - $100,000 a year
EducationSkillsBenefits

JOB OVERVIEW:

This Quality System (QS) Manager is responsible for the leadership and oversight of the Quality Management System which will consist of the following quality system elements: Quality System Management Review (QSMR), CAPA system management, Quality Planning, Quality Metrics, Intra Company Quality Agreement Management, External Standard Management, and Training.

KEY RESPONSIBILITIES:

  • Provide daily leadership and management for the Quality System team.
  • Establish, maintain, and improve the Quality System procedures and processes.
  • Act as QS subject matter expert and resource leader for Quality Assurance to deliver results.
  • Work in a cross-functional environment to identify process and system improvements to enhance efficiency and improve process performance while maintaining compliance.
  • Lead, influence, and negotiate to achieve business strategies and deliver results on time.
  • Develop and implement measures and metrics to monitor QS and present to executive management.
  • Lead Quality System Management Reviews to ensure QS is suitable, adequate, and effective.
  • Provide leadership and oversight of the CAPA system and sub-processes.
  • Establish, maintain and implement Quality System training to the entire organization including a system to maintain training records.
  • Develop annual quality plans and objectives and ensure commitments are met and effective.
  • Serve as technical expert of QS, Management Controls for the organization.
  • Represent QS, Management Controls during regulatory inspections and notified body audit.
  • Provide inspection support; inspection readiness, execution (front room and back room) and post inspection activities.

WORK EXPERIENCE:

  • 5 Years, experience in medical device, pharmaceutical, or other regulated industry is required
  • 3 Years, experience in quality assurance in regulated industry; Medical Device is preferred
  • 2 Years, experience in management is preferred

PREFERRED EDUCATION:

Bachelor of Art or Science Degree, Preferred degree in Engineering, Life Sciences, or Physical Sciences

KNOWLEDGE, SKILLS & COMPETENCIES:

  • Knowledge of 21 CFR Part 820, ISO 13485, MDSAP, MDD/ EU MDR
  • Experience in quality systems within medical device or pharmaceutical industry
  • Experience in training, management reviews, and QS metrics
  • Experience supporting regulatory inspections and audits (i.e. FDA or Notified Body)
  • Experience in computerized quality management systems (i.e. Trackwise, EtQ, Compliancewire, Mastercontrol)
  • Experience in Microsoft Office (i.e. Word, Excel, PowerPoint)
  • Ability to work in a self-directed environment and team environment
  • Ability to influence across functional areas and make change
  • Skilled project manager and change management
  • Critical thinker, detailed oriented, organized, and collaborative
  • Excellent written and oral communication skills
  • Strong leadership and coaching skills

TRAVEL / PHYSICAL DEMANDS:

  • Travel typically less than 20%. Office and factory environment.
  • Job demands may require long periods of sitting, standing, telephone work, computer work
  • Job demands may require may require occasional bending, kneeling, stooping and lifting up to 25 pounds

Job Type: Full-time

Experience:

  • management: 2 years (Required)
  • Quality Assurance (medical Device preferred): 5 years (Required)
  • medical device or related: 5 years (Required)

Education:

  • Bachelor's (Required)

Work Location:

  • One location

Benefits:

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Retirement plan
  • Paid time off