Operations Product Quality Engineer - Supplier Management

Employer
AbbVie
Location
Lake County, IL, US
Posted
Jul 09, 2019
Ref
1904491
Required Education
Bachelors Degree
Position Type
Full time
We currently have an opportunity for a Product Quality Engineer- Supplier 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 day to day supplier management activities for combination products and medical device suppliers. Key responsibility will include quality technical agreements, correspondence, quality management reviews, change planning, SCARs, supplier performance monitoring and product nonconformance support. This position will lead the improvement of existing processes interfacing with supplier and internal groups to resolve problems encountered in the supply chain and assess capability and capacity of suppliers to perform current or potential future work.
This position will be located in our Medical Device Center Headquarters in Waukegan, IL and report directly into Associate Director, Operations Quality.

Responsibilities include:

  • Lead supplier quality development projects and continuous improvement activities.
  • Investigate/coordinate supplier quality issues resolution with the appropriate department, including the dispositioning of non-conforming product, event, deviation, and out of specification reports.
  • Initiate and follow up on Supplier Corrective Action Requests (SCARs).
  • Validate supplier corrective actions involving design and/or process changes to ensure they are robust, sustainable, and implemented for similar potential concerns across manufacturing lines and/or suppliers.
  • Identify Procurement Spec Review and Change Requests.
  • Work with Product Development and Manufacturing/Process Engineers to develop appropriate receiving inspection test methods, sampling plans and acceptance criteria for new and existing components and materials, including first article inspection.
  • Review and monitor strategic supplier performance, including providing trend analysis, investigation, and CAPA for monthly quality review.
  • Liaise with internal customers to ensure effective problem resolution, develop metrics and reports, and identify supplier non-conformance trends.
  • Develop and implement product quality plans, documents and systems by creating product and quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
  • Assist management in implementing and maintaining a quality system that adheres to European, US, Canadian and other regulatory and Quality System requirements (ISO 13485, CFR Part 211/820, Q7/9).
  • Assist with Regulatory Internal or Notified Body audits.
  • Perform continuous improvement activities/projects to improve Product Quality, Compliance, and the Quality System.
  • Provide leadership for New Product Introduction at Suppliers.
  • Plan, execute, and deliver projects effectively within defined time/cost parameters.

Technical and Behavioral Competencies:

  • Excellent knowledge of ICH, US & EU regulations and requirements for 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
  • Adaptable to change in the work environment
  • Ability to work in a fast-paced environment


Requires:

  • 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, injection devices, infusion pumps and supporting ecosystems preferred.
  • 5 plus years of alliance/supplier quality management experience
  • 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