Sr. Quality Engineer

Company Description

Founded in 1912, Illinois Tool Works Inc. (NYSE: ITW) is a diversified, Fortune 200 manufacturing company that delivers specialized expertise, innovative thinking, and value-added products to meet critical customer needs in a variety of industries. Ranked among Fortune’s Magazine’s most admired companies, the company focuses on solid growth, improving profitability and strong returns across its worldwide platforms and divisions. These divisions serve customers and markets around the globe, with a significant presence in developed as well as emerging markets. ITW’s revenues totaled $12.6 billion in 2020.

ITW Medical is comprised of two highly-respected medical product brands - Coeur & Filtertek – supplying medical devices, components, and service to global medical device brands.   Filtertek manufactures molded filtration and flow control components. Coeur is a leading provider of disposable diagnostic imaging consumables. 

Job Description

Position Summary:

The Senior Quality Engineer will work closely with operations and engineering to address issues that can negatively impact our Customer Facing Metrics (OTD and PPM) and to reduce scrap and drive continuous improvement activities for the purposes of reducing customer complaints, lowering response time, and identifying and removing Non-Value Added activities.  This position will investigate internal and external quality issues and use statistical analysis and other tools to identify root cause and effective corrective actions.  This position is responsible for periodic reporting. This position is based in the Washington, NC, manufacturing location and reports to the Quality Manager.

Essential Job Duties and Responsibilities:

• Customer Advocate
  • Able to independently interact with customers to seek information, present ideas or address concerns.
  • Provides appropriate customer communications as required in response to inquiries and/or quality feedback.
• New Product Development
  • Participate in Design Reviews, including Technical Reviews, Feasibility Discussion, and Failure Modes and Effects Analysis (FMEA) creation
  • Assist in documenting development work including supporting writing specifications for manufacturing or identifying and/or evaluating scientific test results
  • Manage Implementation and Documentation of IQ, OQ, PQ.
  • Ensure timely and conclusive validations.
• Process Control
  • Update existing inspection plans, test methods, and standard operating procedures
  • Conduct sample size determination, statistical analysis, training, and root cause analysis
  • Take lead in understanding/updating FMEA for new failure modes
  • Assist in process optimization
• Continuous Improvement
  • Drive and Actively contribute to various manufacturing projects such as process development, cost reduction and quality improvement initiatives
  • Perform routine engineering assignments of related tasks which are typically a focused portion of larger projects.
  • Lead cross-functional teams in continuous quality improvement projects, in particular, in scrap reduction and identification and elimination of non-value-added activities
  • Take lead in collection, review, analysis and trending of quality indicators for monthly and quarterly reviews
  • Manage and contribute to problem solving teams using standardized investigation processes/tools.
  • Evaluate for potential contributors to product defects and/or production delays for the purpose of addressing and correcting them.
• Compliance
  • Participate in the Internal Audit process and assist in addressing observations
  • Participate in customer and regulatory body audits
• Other tasks and duties assigned

Position Skills and Experience Requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. 

• Bachelor’s degree (required) in Biomedical Engineering field (desired).
• 5+ years related experience (required) in Medical Devices Industry (preferred).
• Ability to perform routine design and engineering tasks with some assistance.
• Demonstrated ability to apply statistics to data for use in sample size creation, identification of outliers, verification of conformance with confidence, and evaluation of improvement
• Solid understanding of engineering and mathematics principles.
• Ability to interpret product requirements from drawings, specifications, blueprints, etc. and to identify and drive corrections of inconsistencies or inaccuracies in same
• Able to com