We currently have an opportunity for a Product Quality Engineer/ Risk Management expert who will ensure support of a broad portfolio of on-market medical device and combination products.
The Quality Engineer will lead from a technical quality perspective the preparation of Risk Management plans/reports, risk management file remediation efforts, review/approval of Design Control documents, support design verification/validation activities, and maintain compliance of product/platform design history files.
This position will be located in our Medical Device Center Headquarters in Waukegan, IL and report into Senior Manager, Operations Quality.
• Ensure compliance with global quality systems and Regulatory requirements such as Design Controls, risk analysis/management tools, investigations, CAPAs, etc. to assure product quality
• Perform Design Control activities; ensure design control documentation and design change control requirements are met and appropriately traced throughout the development process and in the design history file for products such as:
• Electromechanical Infusion Pump
• Container Closure Systems
• Enteral and Infusion Tubing
• Connected Medical Mobile Applications
• Drive the creation of an appropriate Risk Management Plan at the start of a project and maintain the plan through all phases of development; support risk assessment activities through UFMEA, DFMEA, PFMEA and other QA risk analysis techniques in order to manage potential risk during development and commercialization
• Advises product teams in a manner to optimize the implementation of risk management strategies for specific risk assessment activities and documents, coordinating and/or authoring documents as appropriate, providing project teams/senior management with a comprehensive recommendation on risk management strategy and remediation.
• Support the sustainability and life cycle management of an existing product.
• PQA point of contact on medical device and combination product development teams and design reviews.
• Provides support for training of team members on design control processes and risk management tools.
• Support manufacturing site inspections/audits for compliance with Design Controls of Combination Products.
Technical and Behavioral Competencies:
• Excellent knowledge of ICH, US & EU regulations and requirements for Risk Management, Medical Device, Combination Product Development & Post-Market Management.
• Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally.
• Proven ability to effectively lead cross-functional teams with respect to risk management activities 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-taking; Ability to understand the sensitivities within the AbbVie's environment.
• Excellent project management and interpersonal skills
• Bachelor's degree in Science, Engineering, or other technical/scientific areas; ASQ preferred
• 7 plus years of experience in the medical device industry; experience with combination products, infusion pumps and supporting ecosystems preferred
• Design Controls experience and strong knowledge of risk management including generation of system risk documentation.
• Working knowledge of ISO 13485, 141971, 21 CFR 4, 21 CFR 820, and MDD
• Working knowledge of medical device international standards
• Working knowledge of problem solving and statistical methods as applied to process and product quality preferred
• Software Life Cycle Management a plus