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Quality Manager

Company: ITW
Location: Washington
Posted on: February 23, 2021

Job Description:

Job DescriptionThis position reports to ITW Medical's Director, Quality & Regulatory Affairs and is responsible for Quality Assurance activities associated with the Imaging Segment of ITW Medical (Coeur, Inc. and Precise Biomedical). 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 Quality System, convert data to information to drive continuous improvement, and manage a team of quality professionals and inspectors (to support their efforts, development, and growth). This position will be responsible for the quality function at the NorthCarolina manufacturing location and for quality communication for key customers of that site.Duties And Responsibiities* North Carolina Site Customer-Facing Metrics (CFM) - Drive actions to improve performance to CFMs o On-Time Delivery - Ensure management of processes to help improve compliance to customer requested delivery dates and investigation of late deliveries to promote improvement. o 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. o 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. o Scrap - Drives improvement in and motivates team member engagement to identify effective solutions for scrap reduction.* Precise Biomedical - Supports Customer, Internal, and Regulatory Audits at Precise Biomedical and fosters improvement in CFM's o New Business o Customer Returns o Repeat Business o Customer ComplaintsDuties And Responsibiities Continued* Compliance/Certification* Maintain the FDA QSR / ISO 13485 - compliant Quality Management System, including acting as primary contact and coordinating training support.* Ensure Management reviews are conducted to provide for systems review.* Manage Internal Audit Program.* New/Change Product/Process Validation o 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.* 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.* Complaint/Corrective Action Management* Act as direct contact (where appropriate) or manage contact 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 o Maintain product supply with minimum Scrap and NVA activities.* Use 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* Partners with our First Team to champion employee engagement efforts.* Manages talent acquisition and develops new hire on-boarding 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 od Quality Management experience, preferably in medical device, required.* 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 InformationITW 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.

Keywords: ITW, Greenville , Quality Manager, Executive , Washington, North Carolina

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