Senior Quality Engineer

Essential Functions:

• Manage improvement projects within Operations department
• Propose and implement improvements utilizing the CAPA and NC systems
• Support all departments to ensure compliance with the QMS and lead continuous improvement efforts of the QMS
• Provide support to all quality activities (i.e. CAPA, NC, Complaint, Change Control, Validation, etc.) via risk-based approach
• Support/Lead QMS audits (internal and external)
• Participant in Management Review (meeting and preparation)
• Work with Corporate Quality on projects
• Ensure alignment between local and corporate procedures
• Monitor quality objective status
• May assign tasks to and direct quality engineers and other quality staff
• May plan and coordinate detailed aspects of work within the quality department
• Other responsibilities as required

Competencies

• Strong communication skills, written and verbal
• Problem solving skills and utilization of tools
• Solid understanding of ISO 13485 and 21 CFR 820
• Detail oriented
• Leadership skills

Desired Qualifications

Required Education:

BS Engineering and/or equivalent work experience

Experience:

2-5+ years of experience in

quality engineering, quality control, quality improvement projects, root cause analysis, CAPA and/or relevant roles.

3+ years of medical device manufacturing and/or experience with 13485 preferred Certified Lead Auditor certification highly preferred (ISO 13485:2016 or ISO 9001:2015)

Experience with Notified Body Audits highly preferred