Quality Engineer

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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.
• Assure compliance to local, divisional, corporate policies and external agency regulations worldwide.
• Primary driver for quality and compliance aspects of Design transfer and on-market change management.
• Serve as 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.
• Own change plans to manage on-market design changes, collaborate with cross?functional team 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 preparation of regulatory inspections and internal audits, representing QA in inspections and audits as SME.
• Participate in development of global Product Quality Assurance strategy to support device and combination products produced at Client plants as well as contract manufacturing and supplier facilities.
• Make recommendations for key decisions on product quality, compliance and regulatory conformance issues.
• Establish and maintain relationships and open communication with suppliers, contract manufacturers, Client plants, affiliates and other functional groups.
• Initiate assignments independently; lead and participate on development and process improvement teams; anticipate / resolve quality issues and take preventive actions.
• Actively monitor effectiveness of processes and quality of project work; propose and execute 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

Mid?Senior level

Employment Type

Full?time

Job Function

Quality Assurance

Industries

Biotechnology Research and Civil Engineering

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