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Quality Engineer III

Quality Engineer III

Katalyst CRONorth Chicago, IL, United States
10 hours ago
Job type
  • Full-time
Job description

Overview

Join to apply for the Quality Engineer III role at Katalyst CRO .

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

  • Bachelor's degree in science, engineering, or other technical areas; or equivalent job experience required. Advanced degree preferred; ASQ certification preferred (CQA, CQE, SSBB, etc.).
  • 8+ years of relevant experience in the medical device industry; at least 5+ years in Quality Assurance experience required.
  • Working knowledge of ISO 13485, ISO 14971, 21 CFR 4, 21 CFR 820, EU Regulation 93 / 42 / EEC (MDD) & 2017 / 745 (MDR).
  • Working knowledge of international standards and regulations applicable to medical devices and combination products.
  • Experience with medical devices and / or combination products such as infusion pumps, PFS, Autoinjector, or Eyecare Products preferred.
  • Ability to apply practical and technical problem solving to quality system and product improvements.
  • Excellent interpersonal skills, including ability to work effectively cross-culturally and cross-functionally.
  • Proven ability to effectively lead cross-functional teams and to influence where direct reporting line relationships do not exist.
  • Capable of developing matrix relationships with key colleagues in other functional areas and divisions; recognizes other colleagues' areas of expertise and utilizes them effectively to achieve team objectives.
  • Champions high quality deliverables, innovation, and appropriate risk-based decision making; ability to understand sensitivities within the
  • 's environment.
  • Excellent project management and interpersonal skills; adaptable to changes in a fast-paced environment.
  • External Manufacturing Business Relationships, Operations, Third Party Manufacturers Business Alliance, Commercial, Global Supply Chain, Domestic and International
  • Plants and Affiliates, Regulatory Affairs, Research and Development.

    • Seniority level

  • Mid-Senior level

    • Employment type

  • Contract

    • Job function

  • Quality Assurance
  • Industries
  • Pharmaceutical Manufacturing

    • 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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