Senior Quality EngineerApply Job ID REF3367G Date posted 08/18/2021 Address 209 Creekside Drive, Washington, NC Job Type Full-time Job Status Exempt
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 $14.1 billion in 2019.
ITW Medical is comprised of three highly-respected medical product brands - Coeur, Filtertek & Precise Biomedical – supplying medical devices, components and service to global medical device brands. Filtertek manufactures molded filtration and flow control components. Precise provides technical service, maintenance & training for contrast media injectors. Coeur is a leading provider of disposable diagnostic imaging consumables.
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.
- Participate in the Internal Audit process and assist in addressing observations
- Participate in customer and regulatory body audits
- Other tasks and duties assigned
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 command use of inspection and measuring instruments such as calipers, micrometers, and tensile strength testers
- Highly motivated, detail-oriented, eager to drive needed change in the organization
- Demonstrated use of strong analytical, problem solving, and teamwork skills in a leadership role
- Able to follow and to provide instructions in all formats: written, verbal, and electronic.
- Excellent time management, prioritization abilities, and strong project management skills
- Ability to develop, implement, and present strategies to gain support
- Strong analytical skills, with 80/20 mindset
- Ability to work with and manage complexity/change such that implementation is simplified
- Demonstrated ability to analyze data and make sound, enterprise-first, decisions
- Excellent interpersonal, communication, and presentation skills
- Ability to generate respect and trust from staff and external constituencies along with the ability to work collaboratively with colleagues and staff to create a results-driven, team-oriented, profitable environment
- Personally driven and able to motivate others to excel
- Ability to use MS Office Tools such as Word, Excel, Project, Access and MiniTab®.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· This position requires some physical movement around the machine areas. This position requires an operator to stand for 90% of their work shift with two scheduled breaks and a 20 minute lunch.
· Some lifting of boxes or totes may be required intermittently.
· While performing the duties of this job, the employee is regularly required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls. The employee is frequently required to reach with hands and arms, stoop, kneel, or crawl; and talk or hear.
· The employee must frequently lift and move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.
ITW offers a competitive compensation and benefits package, including competitively priced medical and dental coverage the first of the month following hire, free life insurance, paid vacation and holidays, and immediate 401k matching. Additional retirement savings contribution (above and beyond 401k) is awarded at no cost after one year.
ITW Medical is an equal opportunity, equal employment, affirmative action employer. We strive to create a diverse and inclusive work environment where everyone is welcome to contribute their unique talents and ideas. We encourage applications from females, males, disabled/protected or other veterans, persons with disabilities, all races and ethnicities, sexual orientations and gender identities. Reasonable accommodation will be made to enable persons with disabilities to apply and to perform the essential job functions. If you require assistance with completing an application, please reply that you require assistance.
All your information will be kept confidential according to EEO guidelines.
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