Supplier Quality Engineering Specialist II

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.

• 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.

• Working knowledge of GMP/cGMP guidelines and international regulations (e.g. 21 CFR 210/211, 21 CFR 11, 21 CFR 820, ISO 13485, Eudralex Volume 4 Part II, ISO 14971, etc.).
• Knowledge of QA concepts related to raw material and supplier management activities.
• Knowledge of QA concepts related to inspection readiness activities.
• Experience with change control process, including ownership of change controls.
• Knowledge of deviation/investigation process, including investigator skills.
• Ability to clearly communicate (verbally & in writing) and work well with suppliers and employees at all levels.
• Ability to effectively collaborate with technical subject matter experts and suppliers.
• Ability to train colleagues on new processes and concepts.
• Procedure and report writing capability (strong technical writing skills)
• Computer literacy in Microsoft Word, Excel, PowerPoint and others as required.
• Independent, organized, and able to schedule work without supervision to meet schedule deadlines.

• Center on People:
  We commit to support the well‑being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile:
  We embody a culture of engagement and action. With a hands‑on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically:
  We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve:
  We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable:
  We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near‑term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

• Bachelor's degree in a…