Quality Manager, Multiple Site

1 week ago

Elk Grove Village, United States Illinois Tool Works Full time

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 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.
This 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.
DUTIES AND RESPONSIBILITIES:
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 – Work 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 – Work with the Plant Management Team and other Team Members to reduce systematic contributors to defects and to ensure appropriate detection practices are implemented.
Scrap – Drive improvement in and motivate 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 Provide partnership with our First Teams to champion employee engagement efforts.
Manage talent acquisition and develop new hire onboarding plans as needed.
Provide frequent performance feedback and complete annual reviews for the team.
Guide the Quality team to manage daily production activities with minimal direct supervision.

Perform other duties as assigned.
MINIMUM REQUIREMENTS:
Bachelor’s Degree in 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.

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