Quality Engineer 1

Base pay range

$29.75/hr - $37.25/hr

Overview

This listing describes the Quality Engineer III position, including responsibilities and qualifications in a regulated environment.

Responsibilities

• Execute to quality system controls in SAP. Assist with release of raw material, component and final product through system controls in SAP.
• Develop, deliver, and drive global QMS projects (transition, due diligence, integration) to ensure compliance to applicable regulations and standards.
• Utilize best practice project management to ensure goals, objectives, and performance metrics are met and/or exceeded. Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility.
• Establish and maintain cross-site communication channels with Quality department stakeholders to ensure Quality department alignment.
• Engage SMEs to validate (i.e. vet with SMEs, stakeholders, and key site Quality personnel) all Quality department ERP requirements before configuration.
• Host design reviews, specifically addressing key Quality decisions, processes, and ERP (and related) configurations.
• Advises and consults on QMS project/quality plans, risk assessments and remediation plans.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Qualifications

• 0-2 years’ experience in quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic manufacturing preferred.
• Knowledge and experience applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD).
• Knowledge and experience with instituting quality controls in an ERP system, SAP preferred.
• Highly effective communication, facilitation and negotiation skills. Adaptable to fast-paced, dynamic work environment with shifting demands. Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position.
• Changes to individual responsibilities may occur due to business needs.

Seniority level

• Associate

Employment type

• Temporary

Job function

• Engineering and Quality Assurance

Job title

Quality Engineer III (PT position 20 hrs. week)