Quality Engineer III

Overview

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Responsibilities

• Represent QA on cross-functional teams and execute Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market.
• Ensure compliance with local, divisional, and corporate policies and external agency regulations worldwide.
• Work with products including medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, pre-filled syringes, autoinjectors, eyecare products, aesthetics devices, etc.
• Lead the quality and compliance aspects of design transfer and on-market change management.
• Serve as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of client.
• Mentor / lead product team members through the design transfer process to ensure an optimal approach.
• Own change plans to manage on-market design changes, collaborate with cross-functional teams for impact assessments, define and execute action plans, and monitor to ensure timely closure.
• Identify gaps / improvement opportunities within the Design History File and Risk Management and track to closure.
• Identify gaps in existing processes and the need for new processes; lead cross-functional teams for solution development and implementation.
• Support the preparation of regulatory inspections and internal audits and represent QA in inspections and audits as SME.
• Participate in developing global Product Quality Assurance strategy to support device and combination products produced at plants as well as contract manufacturing and supplier facilities; implements the agreed strategy.
• Make recommendations for key decisions on product quality, compliance and regulatory conformance issues.
• Establish and maintain relationships with suppliers, contract manufacturers, plants, affiliates and other functional groups to understand quality, compliance, and resource needs at each site and provide guidance on quality concerns.
• Initiate assignments independently; actively lead and participate on development and process improvement teams; anticipate / resolve quality issues and take preventative actions.
• Monitor the effectiveness of processes and project work, propose and implement quality / process improvements; write / review policies / processes / procedures and related documents.
• Conduct, lead, or participate in investigations and review boards for Change Plans, CAPAs, NCRs, Observations, etc.

Requirements

Seniority level

Employment type

Job function

Buffalo Grove, IL — compensation range listed as relevant.

Note : This description reflects the responsibilities and requirements of the role as described by the posting. Referrals may increase interview chances.

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