Quality Engineer III

Company : Katalyst Healthcares & Life Sciences

Responsibilities:

• Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market.
• Responsible for assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide.
• Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetics Devices, etc.
• Primary driver for 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 providing guidance to assure optimal approach.
• 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.
• Ensure design control documentation (Traceability/Linkages) & design change control requirements are met.
• Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
• Assist 3rd party suppliers during change management process, including change management strategies.
• Identify gaps in existing processes as well as 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 the development of global Product Quality Assurance strategy to support device and combination products produced at *** plants as well as contract manufacturing and supplier facilities. Implements agreed strategy.
• Make recommendations for key decisions on product quality, compliance and regulatory conformance issues.
• Establish and maintain relationships and open communication with suppliers, contract manufacturers, *** plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the 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.
• 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:

• 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 the sensitivities within the ***'s environment.
• Excellent project management and interpersonal skills.
• Adaptable to changes in work environment.
• Ability to work 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.

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