Job Purpose
As a Senior Quality Systems Engineer, you will be responsible for ensuring the QMS is established and maintained in accordance with applicable industry requirements. A candidate must have knowledge of quality systems, CAPA, internal audit, and document control. This position is responsible for writing and updating QMS procedures and is accountable for ensuring the NC, CAPA and internal audit programs are defined and 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 the 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
- Prepare and deliver QMS training
- Support the tracking and trending of quality metrics/KPIs (e.g., CAPAs, NCs, SCARs, complaints, deviations, internal audit findings, calibration and PM, etc.)
- Identify areas of improvement through data-driven trending and brings solutions to management
- Lead/support significant Quality System projects effectively
- Develop innovative and practical solutions to complex and unique process problems and system improvement 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 QA/RA Leadership
- Support/execute other QMS elements as needed
Qualifications
- 5+ years experience working in a regulated field with experience in quality systems
- 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
- Experience in audit support
- Experience leading and influencing across functional groups and leadership levels
- Working knowledge of ISO 13485, ISO 9001, and AS9100
VulcanForms offers a competitive salary and equity package. Actual compensation is based on factors such as the candidate's skills, qualifications, and experience. In addition, VulcanForms provides comprehensive benefits including medical, dental, vision, and life insurance; generous paid time off; and a 401(k) plan with company match.
The annual base salary range for this position is $90,104 to $123,893.