Director of Quality Engineering

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

We are partnering with a growing medical device company who creates Class III devices in the US. The product is already sold in Europe, Canada, Australia and several other markets.

With commercial launch underway, new sizes and instruments in development and a clinical study planned to expand the indication, the company is building out its quality function. This is a senior, hands on leadership role in a small, experienced team, reporting to the VP of Regulatory Affairs and Quality Assurance.

You will own quality engineering across design, manufacturing and suppliers, and build the processes and team that take a newly approved Class III product through commercial scale up.

What you will do

• Lead quality engineering for a Class III implant across design control, manufacturing and post-market
• Own design assurance for new sizes, instruments and product changes: design verification and validation, design reviews, design history files and risk management to ISO 14971
• Lead supplier and contract manufacturer quality: qualification, audits, supplier controls, incoming inspection and process validation (IQ/OQ/PQ)
• Oversee nonconformance, CAPA, complaint handling and investigations, and drive trend analysis and continuous improvement
• Support change control and work with Regulatory Affairs on the impact of changes to PMA, EU MDR and international registrations
• Lead quality support for sterilisation, biocompatibility, packaging and shelf-life validations
• Strengthen the QMS to ISO 13485, 21 CFR 820 / QMSR and MDSAP, and act as a lead for FDA, notified body and MDSAP audits
• Build, mentor and grow the quality engineering team as the company scales

Must have

• Bachelor's degree in engineering (mechanical, biomedical, materials or similar)
• 10+ years of quality engineering in medical devices, with 3+ years leading quality engineers
• Experience with Class III or implantable devices
• Strong design control, risk management (ISO 14971) and process validation background
• Supplier quality and contract manufacturer management, including audits
• Working knowledge of ISO 13485, 21 CFR 820 / QMSR and EU MDR quality requirements
• Experience hosting or supporting FDA and notified body audits
• Comfortable being hands-on in a small company while building systems for growth

Nice to have

• Experience supporting a product through PMA approval and commercial launch
• Knowledge of sterilisation, packaging and biocompatibility validation