Senior Quality Engineering Leader – Medical Devices (Class III)

Codon Partners; Denver (CO); On-site; USD 180,000 - 240,000; Full time

Job summary

Codon Partners is seeking a senior Quality Engineering Leader for a growing medical device company. You will own quality across design, manufacturing and suppliers, driving ISO 13485 and regulatory readiness for PMA and EU MDR.

The role also focuses on continuous improvement, CAPA and audits as the organization scales. You will mentor a hands-on team in a fast-paced environment, ensuring robust design verification/validation and supplier quality that supports commercial scale-up and post-market

Qualifications

• Senior quality leadership for Class III medical devices with design control expertise.
• Strong background in ISO 13485, 21 CFR 820 / QMSR and EU MDR requirements.
• Experience with audits by FDA and notified bodies and PMA programs.
• Hands-on ability to build and scale a quality function in a small company.

Responsibilities

• Lead quality engineering across design, manufacturing and suppliers.
• Own design assurance for new sizes, instruments and product changes: V&V, DHF and risk management.
• Lead supplier and contract manufacturer quality: audits, qualification, controls and IQ/OQ/PQ.
• Oversee nonconformance, CAPA, complaint handling and investigations; drive trends.
• Support change control and liaise with Regulatory on PMA, EU MDR and registrations.
• Lead sterilisation, biocompatibility, packaging and shelf-life validations.
• Strengthen the QMS to ISO 13485, 21 CFR 820 / QMSR and MDSAP; prepare audits.
• Build, mentor and grow the quality engineering team as the company scales.

Skills

Quality engineering leadership

Design control

Risk management (ISO 14971)

Supplier quality management

Audits (FDA/Notified bodies)

CAPA & corrective actions

Regulatory compliance knowledge

Process validation (IQ/OQ/PQ)

Hands-on leadership in small teams

Continuous improvement

Education

Bachelor's degree in engineering

Job description

Codon Partners is seeking a senior Quality Engineering Leader for a growing medical device company. You will own quality across design, manufacturing and suppliers, driving ISO 13485 and regulatory readiness for PMA and EU MDR.

The role also focuses on continuous improvement, CAPA and audits as the organization scales. You will mentor a hands-on team in a fast-paced environment, ensuring robust design verification/validation and supplier quality that supports commercial scale-up and post-market