Senior Engineer, Supplier Quality – GMP Compliance & Audits

Axogen, Inc.; Vandalia (OH); Presencial; USD 84 000 - 105 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health

Dental

Vision

401k matching

Paid time off

Floating holidays

Tuition reimbursement

Parental leave

Stock purchase plan

Disability insurance

Resumo da oferta

Axogen, Inc. is seeking a Sr. Engineer, Supplier Quality to lead the Supplier Quality Management Program and ensure GMP compliance across CSPs. You will audit suppliers, develop quality agreements, and maintain supplier qualifications while collaborating with cross-functional teams.

You will drive continuous improvement, manage multiple priorities, and support regulatory inspections with strong communication and organizational skills.

Qualificações

• This role requires a Bachelor's degree in sciences with 5+ years in GMP environments.
• Experience auditing in pharmaceutical/medical device industries (min 2 years).
• Knowledge of quality principles, and 21 CFR, ISO, ICH guidelines.
• Experience with supplier quality management and CSP oversight.

Responsabilidades

• Manage the Supplier Quality Management Program for contract service providers.
• Lead GMP supplier audits, coordinate assignments, schedules, and closures.
• Create and maintain Supplier Quality Agreements.
• Maintain Approved Supplier List and qualification statuses.
• Collaborate with SMEs to support supplier selection and KPIs.

Conhecimentos

Auditing

Quality communication

Interpersonal skills

Decision making

Self-starter

Detail oriented

Time management

Problem solving

Formação académica

Bachelors in sciences (biology/chemistry/biochem/chemical engineering)

Quality auditor certification (preferred)

Ferramentas

GxP standards knowledge

Descrição da oferta de emprego

Axogen, Inc. is seeking a Sr. Engineer, Supplier Quality to lead the Supplier Quality Management Program and ensure GMP compliance across CSPs. You will audit suppliers, develop quality agreements, and maintain supplier qualifications while collaborating with cross-functional teams.

You will drive continuous improvement, manage multiple priorities, and support regulatory inspections with strong communication and organizational skills.