QMS Specialist

At-a-Glance:

Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a QMS Specialist.

Position Type:

• Contract
• Remote
  
  
  

Required:

• Bachelor's degree in a technical or scientific discipline, or equivalent experience in quality systems within a regulated industry.
• 2-4 years of experience in Quality Management Systems, preferably in the medical device or other regulated industries.
• Working knowledge of QMS processes, including CAPA, Document Control, Management Controls, and Training.
• Familiarity with medical device regulatory requirements, including FDA 21 CFR 820 and ISO 13485.
• Strong analytical, organizational, and problem-solving skills, with the ability to manage multiple remediation activities.
• Excellent technical writing and communication skills, including the ability to develop clear documentation and collaborate with cross-functional teams.
• Detail-oriented with the ability to execute quality system processes accurately and consistently in a fast-paced remediation environment.
  
  
  

Responsibilities:

• Support execution of QMS remediation activities within assigned workstreams, ensuring timely completion of corrective actions and process improvements.
• Collaborate with the QMS Strategic Lead to implement and maintain robust QMS processes aligned with regulatory requirements and organizational objectives.
• Participate in CAPA investigations and remediation activities, including root cause analysis, effectiveness checks, and implementation of sustainable corrective actions.
• Assist in the development, revision, and implementation of QMS procedures and documentation related to CAPA, Management Controls, Document Control, and Training.
• Contribute to the implementation of metrics, monitoring mechanisms, and process controls to ensure ongoing compliance and prevent recurrence of issues.
• Provide training, consultation, and support to cross-functional teams on quality system processes, regulatory expectations, and best practices.
• Collaborate with internal stakeholders across multiple sites to promote a culture of quality, accountability, and continuous improvement.
  
  
  

Get in Touch:

We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Priyanshu at 201-478-6913 to learn more.

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