Quality Engineer

Accountable for quality system compliance with ISO requirements, including transition and maintenance of ISO 9001:2008 system to ISO 9001:2015 standard.

Accountable for compliance of GMP processes with ICH Q7 and other applicable regulations.

Accountable for delivery and maintenance of site AS9100 certification.

Accountable for delivery and maintenance of site Food Safety Modernization Act (FSMA) certification.

Support regulatory and customer inspections (quality), including questionnaires and desk audits.

Remain current with required training for ISO 9001 and AS9100 compliance, potentially including lead auditor training.

Remain current with required GMP training.

Act as site Preventive Control Qualified Individual for FSMA compliance.

Management of site CAPA system, including verification activities.

Support GMP regulatory efforts (Certificate of Suitability, Drug Master File, etc…) as needed.

Act as backup for day-to-day GMP tasks for Quality Coordinator and QC Team Leader.

Develop into Site Quality Unit (European GMP definition) for product release and quality investigations.

Qualifications

REQUIREMENTS & SKILLS:
Requires a BS in Chemistry, Chemical Engineering or Mechanical Engineering with 4 or more years of experience in the chemical, aerospace or pharmaceutical manufacturing industries. In lieu of a degree, we will consider applicants with 10+ years of aerospace industry experience.

Preferred experience with: AS9100, GMP and/or auditing

Demonstrate the ability to influence peers and cross-functional stakeholders in a positive manner.

Effectively build and maintain strong relationships with internal and external customers.

ISO, AS, GMP requirements

SAP and related Solvay software tools

Organizational hierarchy and accountabilities

Travel – 10%

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Primary Location

:

USA-West Virginia-Willow Island

Standard

–

Full-time

Experience requested

:

Experienced