Sr. Quality Systems Engineer

Job Purpose: As aQuality Systems Engineer, you will be responsible for helping to ensure the QMS is established and maintained in accordance with applicable regulatory requirements. A candidate must have knowledge of quality systems, CAPA, NCR, and document control. This position is responsible for writing and updating QMS procedures and is accountable for ensuring quality processes are executed compliantly. QMS compliance will be met by ensuring that activities previously noted are conducted according to prescribed procedures, policies, and regulations.

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

Preferred Qualifications: Experience with Start-ups