Quality Engineer 1

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 levelAssociate Employment typeTemporary Job functionEngineering and Quality Assurance Job titleQuality Engineer III (PT position 20 hrs. week)