Senior Quality Leader: Full QMS Ownership & Audit Lead

Rise Technical; Jamestown (NY); On-site; USD 100,000 - 120,000; Full time

Job summary

Rise Technical is seeking a Senior Site Quality Leader to own the site QMS in Jamestown, NY, overseeing audits, CAPA, complaints, supplier quality, and documentation. You will serve as Management Representative and guide five direct reports, with responsibility for cross-functional quality decisions at the site.

Ideal candidates will have 5+ years in quality management within a medical device or diagnostics setting, a relevant bachelor’s degree, and a track record of driving compliance and

Qualifications

• 5+ years’ Quality management experience with QMS ownership, audits, and CAPA/root cause
• Bachelor’s degree in QA, Engineering, Life Sciences, or related field
• Experience leading a team and working in a regulated medical device or diagnostics environment

Responsibilities

• Senior site Quality leadership with full QMS ownership
• Lead audits, CAPA, complaints, supplier quality, and continuous improvement
• Act as Management Representative; make final site quality decisions
• Lead and develop a team of five direct reports
• Site-based role in Jamestown, NY

Skills

Quality management

QMS ownership

Audits

CAPA

Root cause analysis

Team leadership

Regulatory compliance

Education

Bachelor’s degree in Quality Assurance, Engineering, Life Sciences, or related field

Job description

Rise Technical is seeking a Senior Site Quality Leader to own the site QMS in Jamestown, NY, overseeing audits, CAPA, complaints, supplier quality, and documentation. You will serve as Management Representative and guide five direct reports, with responsibility for cross-functional quality decisions at the site.

Ideal candidates will have 5+ years in quality management within a medical device or diagnostics setting, a relevant bachelor’s degree, and a track record of driving compliance and