Manager, QA Device Products

Lake County, Illinois, USA
May 08, 2018
Required Education
Bachelors Degree
Position Type
Full time
Responsible for driving life cycle management of Medical Devices and critical molded components (New Product Introduction & On-Market Support). Leverage molding technology / device experience in order to act as molding / assembly of molded components quality SME for internal AbbVie and external key stake holders. Responsible for quality of assigned molded components to ensure business objectives are met with regards to on time delivery of molded components and /or assembly of molded components while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Manage quality relationship with assigned molded component suppliers to ensure compliance with AbbVie requirements, adherence to applicable regulations and utilization of industry best practices for molding operation. Grade is commensurate on level of overall responsibility. This role will support the strategic direction to ensure business objectives are met to support and sustain the Combination Products, Pharmaceutical products, and medical devices. Complete quality assurance activities to develop, implement and sustain required device regulations to comply to global medical device and Combination Product Regulations. Assure proper integration and support of device regulations, drug regulations and as appropriate, biologics regulations.

Key Responsibilities Include:

  • Drive Lifecycle Management of Medical Devices and critical molded components through new product introduction and on market support. Support design changes to existing medical devices and combination products. Understand sources of engineering and sustain engineering.
  • Leverage platform technology to understand design space and relationships that design outputs and environmental factors have on the design space (design and process).
  • Utilize risk management and failure analysis proactively to anticipate events and implement mitigation.
  • Work with external and internal partners to establish best in class practices for assigned molded critical components, devices, biologics or combination products. Participates in the development of global Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products produced at AbbVie plants as well as third party manufacturing (TPM) facilities. Implements agreed strategy.
  • Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products / critical molded components and elevates medium and high risk events to AbbVie management.
  • Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Helps facilitate resolution in cases where they are not.
  • Establishes and maintains relationships and open communication with Molded Component Suppliers, AbbVie 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.
  • Perform base business quality assurance activities for assigned products and suppliers, including supplier management, product annual review, design transfer, design verification/validation, change control, complaint trend investigation and exception reporting.
  • Completes management reviews with assigned Molded Component Suppliers that identify and address quality, operational, and organizational issues and track supplier performance metrics to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner.
  • Provides quality oversight and support for both external and internal assembly operations utilizing critical molded components. Assists in resolving quality issues pertaining to molded components used in assembly.
  • Bachelor Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area.
  • 7+ years of total combined experience. At least 5 years in Quality Assurance Operations Management in a medical device setting and 3 years supporting medical device component molding and/or assembly operations. Direct experience as a molding engineer is preferred.
  • Skilled in risk management principles and quality engineering applications.
  • Knowledge of regulations and standards affecting devices, biologics and pharma products. Knowledge of ISO standards, US Code of Federal regulations, and the EU regulations. Previous experience with regulatory agency interface preferred.
  • Knowledge and a comprehensive understanding of some biological, device and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients).
  • Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members and individuals.
  • Leadership of other technical professionals and experience in leading cross-functional teams with results-orientation.
  • Skilled in the strategy development, initiation, selection, coordination and management of projects and have the ability to solve unique problems.
  • Understands impact of specific area system changes to other quality systems as well as changes within requirements and impact to specific area of control and able to adjust accordingly.

Key Stakeholders:
External Manufacturing Business Relationships, Operations, Suppliers, Business Alliance, Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, Research and Development.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

  • 20% Travel