Company DescriptionFounded 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 anITW Medical is comprised of two strong medical product brands - Coeur and Filtertek - able to proactively meet the needs of customers in the marketplace. Coeur is a leading provider of disposable medical products used in diagnostic imaging and other medical procedures. The Filtertek product line is comprised of custom plastic insert molded filtration and flow control components for global OEM medical device customers. d components to global medical device brands. Filtertek manufactures molded filtration and flow control components. Coeur is a leading provider of disposable diagnostic imaging consumables. Job DescriptionThis position reports to ITW Medical's Director, Quality Assurance & Regulatory and is responsible for Quality Assurance activities associated with the Hebron and Elk Grove Village, IL, sites and will maintain an office in Illinois. The individual will be responsible for compliance/certifications, complaints/corrective actions, and for the financial aspect of the quality function specifically tied to ownership of scrap and non-value-add activity reduction. This individual will champion the use of the Divisional Quality Management System, drive a culture change away from quality control and towards quality assurance, leverage analytics and strategic decision making to drive continuous improvement, and lead a team of quality professionals and inspectors. This position will be responsible for the quality function at the Hebron and Elk Grove Village, IL, manufacturing locations and for quality communication for key customers of those sites, and the division.DUTIES AND RESPONSIBIITIES:
- Customer-Facing Metrics (CFM) - Drive actions to improve performance to CFMs
- On-Time Delivery - Ensure management of processes to help improve compliance to customer requested delivery dates and investigation of late deliveries to promote improvement.
- Complaint Response Time - Works with Quality Team, Peers, and other Team Members to ensure complaints are properly investigated, acted upon and responded to in a timely manner.
- Complaint PPM - Works with the Plant Management Team and other Team Members to reduce systematic contributors to defects and to ensure appropriate detection practices are implemented.
- Scrap - Drives improvement in and motivates team member engagement to identify effective solutions for scrap reduction.
- Compliance/Certification
- Maintain the FDA QSR / ISO 13485 - compliant Quality Management System, including assignment of primary contacts and coordinating training support. Ensure 100% alignment with Divisional Standards.
- Ensure Management reviews are conducted to provide for systems review.
- Manage Internal Audit Program.
- New/Change Product/Process Validation
- Oversee management of validation activities
- Ensure appropriate protocols are written, identified actions are completed, inclusive reports are written.
- Management of Implementation and Documentation of IQ, OQ, PQ
- Ensure timely and conclusive validations, including validation reports.
- Participate in Design Reviews, including Technical Reviews, Feasibility Discussion, and Failure Modes and Effects Analysis (FMEA).
- Assist in documenting development work including supporting writing specifications for manufacturing or identifying and/or evaluating scientific test results.
- Complaint/Corrective Action Management
- Act as direct contact (where appropriate) or manage contact (through Quality Engineers) for customer quality-related issues; coordinate course of action for alleviating and resolving concerns and providing timely responses.
- Identify corrective/preventive actions for continuous improvement (effectively implemented and closed in a timely manner) and quality improvement as needed for Production and Business Unit Goals.
- Ensure completion of necessary paperwork such as CAPACIAs, Alerts, and other relevant documents.
- Ensure Root Cause Analyses are conducted to establish reasons and solutions for Quality matters.
- Financial Management with Plant Management Teams and Reports for Process/Cost Control
- Maintain product supply with minimum Scrap and NVA activities.
- Drive improvement by using data-based information to drive Scrap Reduction, elimination of NVA activities, and On-Time Delivery improvement to drive action needed for the QRTF (Quality & Regulatory Task Force).
- Use charts/graphs/data to lead/support scheduled meetings.
- Offer input for areas of improvement in products, processes, and procedures.
- Manage Department
- Provides partnership with our First Teams to champion employee engagement efforts.
- Manages talent acquisition and develops new hire onboarding plans as needed.
- Provides frequent performance feedback and completes annual reviews for the team.
- Guides the Quality team to manage daily production activities with minimal direct supervision.
- Performs other duties as assigned.
Qualifications
- Bachelor's Degree Business Administration, Engineering or related field required, certification to internal auditing preferred.
- 5-7 years Quality Management experience, with multi-site experience (with global cultural awareness), preferably in medical device, required.
- Strong P&L Leadership, financial acumen.
- Experience driving zero PPM in a lean manufacturing environment. Knowledge/experience with ISO 13485 and 21 CFR 820, or equivalent, quality system requirements required.
- Ability to use MS Office Tools such as Word, Excel, Project (or other project management software), Access and MiniTab® (or other statistics software).
- Ability to build respect/trust within internal staff/other functional leaders as well as external customers.
- Excellent interpersonal, communication (verbal and non-verbal), and presentation skills.
- Possesses excellent time management, prioritization abilities, and strong project management skills.
- Highly motivated, detail-oriented, and eager to drive needed change.
- Demonstrated ability to autonomously make strategic decisions.
- Must possess comprehension and reasoning skills used to understand and collect data, interpret technical instructions, and draw valid conclusions.
- Ability to apply advanced mathematical concepts and theory such as geometry, statistics, algebra, calculus, and differential equations to address engineering issues.
- Demonstrated ability to analyze data and make sound, enterprise-first, problem-solving decisions.
- Ability to travel occasionally to other ITW locations and for customer visits.
Additional InformationAll your information will be kept confidential according to EEO guidelines.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 assistanceITW is an equal opportunity employer. We value our colleagues' unique perspectives, experiences and ideas and create workplaces where everyone can develop their careers and perform to their full potential. As an equal employment opportunity employer, ITW is committed to equal employment opportunity and fair treatment for employees, beginning with the hiring process and continuing through all aspects of the employment relationship. All qualified applicants will receive consideration for employment without regard to race, color, sex, gender identity, sexual orientation, religion, national origin, age, disability, protected Veteran status or any other characteristic protected by applicable federal, state, or local laws.