Senior Quality Engineering Manager, Combination Product Nearing FDA Clearance | 3663900

Pave Talent; Gaithersburg (MD); Presencial; USD 150.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Platinum PPO medical

Dental

Vision

401(k) match

15 vacation days

10 holidays

Relocation assistance

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Quality management

CAPA

Nonconformances

Document control

Training

Supplier controls

Audit readiness

IQ/OQ/PQ

Process validation

Regulatory compliance

Contractor management

Educación

Engineering or science degree

ISO 13485 lead auditor certification

Descripción del empleo

A build seat, not a maintenance seat. Our client is a small medical technology team taking a combination product through FDA clearance and into commercial manufacturing, and the quality program has to be ready before the product is. You set the priorities, run the quality system, and direct the outside validation firms that carry much of the equipment and process work, working directly with the executive team.

Qualifications and responsibilities

• You are a senior quality engineering manager or quality manager ready to run quality for a whole program.
• When there is more work than time, you decide what matters and can say what you chose not to do.
• You tell leadership about a problem before anyone asks.
• The quality system day to day: CAPA, nonconformances, document control, training, supplier controls and audit readiness.
• The validation program for equipment, processes and test methods, including the outside firms that execute much of it.
• Quality engineering through scale-up and the first commercial builds, plus the risk files behind clearance and launch.
• Straight, early reporting to leadership on where quality stands.
• Ten or more years in medical device or combination product quality in manufacturing, including time leading quality engineers.
• IQ, OQ, PQ and process validation you have written and run yourself, not only approved.
• ISO 13485 and FDA's quality system regulation in practice, including FDA inspections or notified body audits.
• Experience directing contractors or an outside validation firm, and a degree in engineering or science.
• A plus: combination product experience, sterilization validation, or ISO 13485 lead auditor certification.

Base salary of $150,000 to $180,000, plus bonus and equity eligibility.

• Platinum PPO medical with no in-network deductible
• dental
• vision
• a 401(k) match that vests immediately
• 15 vacation days plus 10 holidays to start
• Relocation assistance is available

Pave Talent and our client are equal opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable law.