Supplier Quality Engineering Specialist I (Onsite)

Description

Core Hours : Monday - Friday, 8am-5pm

Purpose and Scope

The Supplier Quality Engineering Specialist I is primarily responsible for supporting supplier quality related processes including Contract Manufacturing / Packaging Organizations (CMOs / CPOs). This position also supports site inspection readiness activities.

Essential Duties & Responsibilities

• Support the Supplier Change Notification Program, including completion of impact assessments.
• Own supplier-related quality events (deviations) and supplier corrective action reports (SCARs), including completing investigations and collaborating with technical subject matter experts and suppliers.
• Support the supplier complaint process as assigned.
• Support quality agreement program, including initiating and coordinating quality agreements with suppliers and other third parties.
• Support supplier audit program as assigned.
• Support supplier qualification and re-evaluation programs, including performing historical quality reviews, impact assessments, risk assessment and completing summary evaluations.
• Submit and monitor revisions to current department procedures.
• Assemble, review and submit supplier quality information to APQR team for annual reports.
• Perform supplier site visits to assist with supplier investigations as assigned.
• Support audit and inspection readiness activities, including providing training on associated processes / concepts to all levels of employees.
• Support post-audit and inspection activities (e.g. coordinating meetings, compiling data, etc.).
• Assist in preparing for and hosting external audits and inspections (FDA, Notified Body, Marketing Partners, etc.) including serving as a scribe, request taker or a "back room" support.
• Perform other duties as assigned.

Knowledge, Skills & Abilities

Core Values

Education & Experience

Working Conditions

Compensation and Benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.