Quality Manager - Medical Devices

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

$100,000 - $120,000 + Senior Site Leadership + Full Quality Ownership + Team Management + Long-Term Stability

Jamestown, NY (Commutable from: Dunkirk, Fredonia, Westfield, Lakewood, Falconer, Olean, Warren PA)

Are you a Quality Manager or senior Quality leader looking for the chance to take full ownership of a site QMS, make the final decisions, and lead a team in a regulated medical device / diagnostics environment?

On offer is a key leadership opportunity within an established global diagnostics business where you will have real authority across the site’s quality function, with responsibility for driving compliance, audit readiness, and continuous improvement.

You will be joining a well-established manufacturer of diagnostic instruments, medical devices, and test kits, known for operating in highly regulated environments and delivering high-quality products. Due to continued growth and site expansion, they are now looking to add a senior Quality leader to strengthen internal compliance capability.

In this role you will act as Management Representative and own and maintain the site QMS, lead internal/external/regulatory audits, and manage CAPA, complaints, supplier quality, and documentation. You will lead and develop five direct reports, with oversight that includes support to one engineer at another site.

This role would suit a Quality Manager / Head of Quality from a medical device or diagnostics background, looking for genuine ownership, the chance to lead a Quality team, and the authority to drive standards across the site.

The Role:

• Senior site Quality leadership role 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 (incl. oversight supporting Buffalo)
• Site-based role in Jamestown, NY

The Person:

• Quality Manager, Director or Lead with medical device or diagnostics experience
• 5+ years’ Quality management experience with QMS ownership, audits, and CAPA/root cause
• Bachelor’s degree in Quality Assurance, Engineering, Life Sciences, or related field

Reference Number: BBBH279636

We are an equal opportunities company and welcome applications from all suitable candidates.