Quality Systems Engineer

Key Responsibilities

• Ensure that a Quality System is established and maintained to the highest levels of accordance with applicable regulatory requirements
• Write, review, and approve the release of changes to QMS documentation
• Support the NCR program
• Support the internal audit program
• Support the CAPA program
• Support the preparation of Management Review
• Support the QMS training program
• Work with other functions to ensure accurate, complete, and efficient change processing and document control activities
• Support the tracking and trending of quality metrics/KPIs (e.g., CAPAs, NCs, SCARs, complaints, deviations, internal audit findings, calibration, etc.)
• Identify areas of improvement through data-driven trending and bring solutions to management
• Lead/support Quality System projects effectively
• Develop innovative and practical solutions to complex and unique process problems and systematic improvements through the use of best practices
• Identify/escalate any compliance issues and their potential impact and provide potential solutions/actions so that they can be effectively resolved
• Support audits and inspections as needed (e.g., coordinate preparation activities, FR/BR support, track resolution activities)
• Lead or support additional projects as assigned by QS Leadership

Qualifications

• 3+ years’ experience working in the medical device or aerospace fields with experience in FDA regulatory requirements, ISO 13485, and/or AS9100/ISO9001
• Experience in writing QMS procedures
• Experience in NCR and CAPA
• Excellent communication, interpersonal and leadership skills
• Experience working with and evaluating Quality metrics and KPIs

Pay

The annual base salary range for this position is $75,413.00 to $103,692.00.