Senior Quality Engineering Leader for Medical Device

Pave Talent; Gaithersburg (MD); On-site; USD 150,000 - 180,000; Full time

Benefits offered by this job

Platinum PPO medical

Dental

Vision

401(k) match

15 vacation days

10 holidays

Relocation assistance

Job summary

Pave Talent seeks a senior quality engineering leader to own quality for a full medical device program. You will direct CAPA, document control, supplier controls and audit readiness, while coordinating validation with outside firms and the executive team.

With 10+ years in medical device quality, you will lead engineers, ensure IQ/OQ/PQ execution, and drive ISO 13485 and FDA QSR compliance through launch.

Qualifications

• 10+ years in medical device or combination product quality in manufacturing.
• Experience directing contractors or outside validation firms.
• IQ, OQ, PQ and process validation you have written and run yourself.
• ISO 13485 and FDA QSR; including inspections or audits.
• Leadership experience: lead quality engineers.

Responsibilities

• Run the quality system day to day: CAPA, nonconformances, document control, training, supplier controls and audit readiness.
• Direct the validation program for equipment, processes and test methods, including outside firms that execute much of it.
• Lead quality engineering through scale-up and the first commercial builds, plus the risk files behind clearance and launch.
• Report to leadership on where quality stands.
• Set priorities when workload exceeds time and decide what to deprioritize.

Skills

Quality management

CAPA

Nonconformances

Document control

Training

Supplier controls

Audit readiness

IQ/OQ/PQ

Process validation

Regulatory compliance

Contractor management

Education

Engineering or science degree

ISO 13485 lead auditor certification

Job description

Pave Talent seeks a senior quality engineering leader to own quality for a full medical device program. You will direct CAPA, document control, supplier controls and audit readiness, while coordinating validation with outside firms and the executive team.

With 10+ years in medical device quality, you will lead engineers, ensure IQ/OQ/PQ execution, and drive ISO 13485 and FDA QSR compliance through launch.