Supplier Quality Engineering Specialist II

Description

Purpose and Scope

The Supplier Quality Engineering Specialist II is primarily responsible for supporting and managing supplier quality related processes including Contract Manufacturing / Packaging Organizations (CMOs / CPOs) and Tolmar site inspection readiness activities.

Essential Duties & Responsibilities

• Manage the Supplier Change Notification Program, including completion of impact assessments.
• Own supplier-related quality events (deviations) and supplier corrective action reports (SCARs), including completing the investigation of the event and collaborating with technical subject matter experts and suppliers.
• Support quality agreement program, including initiating and coordinating quality agreement drafts.
• Support the internal and supplier audit programs, including planning and performing the audit, report development, follow up, etc. under supervision of Quality Auditor.
• Support the supplier qualification and re-evaluation programs, including performing historical quality reviews, impact assessments, risk assessments and completing summary evaluations.
• Support and own initiation of new procedures and revisions to current department procedures.
• Assemble, review and submit supplier quality information to support APQR team for annual reports.
• Perform supplier site visits to assist with supplier investigations as assigned.
• Support and manage audit and inspection readiness activities, including providing training on associated processes / concepts to all levels of employees.
• Assist in preparing for and hosting external audits and inspections (FDA, Notified Body, Marketing Partners, etc.) including serving as a scribe, request taker, subject matter expert (SME) or "back room" support.
• Support post-audit and inspection activities (e.g. coordinating meetings, compiling data, etc.).
• Other duties as assigned.

Knowledge, Skills & Abilities

Core Values

The Supplier Quality Engineering Specialist II is expected to operate within the framework of Tolmar's 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.