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Quality System Specialist

Pewaukee, Wisconsin NeoCoil LLC

Job Description

NeoCoil, LLC is a leader in MRI coils and imaging accessories designed for better patient comfort and experience. Our focus, through innovation and precision, is to engineer and manufacture the highest quality coils and accessories for the medical industry. Due to our growth and continued success, we are seeking an experienced Quality System Specialist to join our team.

This role has responsibility to support the required maintenance of and drive continuous improvement to the Quality Management System and manufacturing activities. You will work collaboratively with Manufacturing and Engineering to develop and maintain Quality metrics to drive process improvements. Having a solid understanding of applicable medical device regulations (i.e. CFR, ISO 13485, MDD).

Primary Responsibilities:

– Coordinate NCMR process activities: containment for defective parts on the floor, investigate potential impacts / risks of part nonconformities and determine nonconforming part dispositions, attend NCMR Meetings and approve NCMR dispositions.
– Drive root cause analysis of quality issues and development of long term, cost effective solutions as well as a ‘preventative’ mind set to anticipate future occurrences.
– Support Service / Complaint handling by coordinating investigation, performing trend review, and assuring complaint files are completed in a timely manner complaint with within QMS requirements.
– Participate in Supplier Quality initiatives by facilitating communications with suppliers on quality related issues, participating in supplier visits, audits and surveys, and coordinate cross functional teams to address supplier quality concerns.
– Participate in design transfer activities for new product launches to ensure design specifications are met fully understood and corresponding actions being implemented
– Participate in the development and review of manufacturing process risk documentation (PFMEA, control plans)
– Provide support to project teams to ensure quality system and regulatory compliance.
– Ensure the correct implementation, integrity and compliance of the Device Master Record as part of manufacturing activities.
– Initiate, review and approve Change Orders for Quality System documentation and Manufacturing Device Master Record specifications.
– Support/lead internal and supplier audits.
– Support/lead investigations and implementation of planned actions stemming from the Corrective and Preventive Action program.
– Support/perform statistical analysis such as Gage R & R studies, process capability studies, etc.
– Perform product/process analysis for quality improvement, efficiency gains and cost reduction.
Minimum Requirements and Characteristics:

– Bachelor’s Degree in Engineering (Electrical or Mechanical preferred) or related field and a minimum of 3 years’ Quality experience.
– Experience in the medical device industry.
– Analytical problem solving. The ability to go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
– Motivation. An individual who brings strategic direction and inner drive for execution to ensure products are developed, launched, and sustained with precision.
– Collaboration. The ability to build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
– Ability to read/interpret electrical and/or mechanical specifications.
– High level of attention to detail and the ability to manage several concurrently assigned tasks.
– Serve as a resource and mentor to colleagues with less experience.
– Possess good interpersonal and communication skills; promote a collaborative environment.
– Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
– Expertise in the operation of quality control systems, application and analysis of testing and inspection procedures, and the ability to use metrology and statistical methods to diagnose quality issues.
– Understanding of usability, familiarity with quality costs, concepts and techniques, and auditing of quality systems for deficiency identification and correction.
– Working knowledge and proficiency with various software programs (MS Office including Outlook, Word and Excel).
Desired Experience and Characteristics:

– Experience participating in external audits.
– Experience using Minitab or other statistical analysis modalities.
– Experience with SolidWorks or CAD software.
– Familiar with Enterprise resource planning (ERP) software and defect tracking software.
NeoCoil LLC is committed to a policy of equal employment opportunity. The Company conducts all employment practices without regard to race, sex, color, religion, national origin, age, disability, protected veteran’s status, sexual orientation or any other basis prohibited by law. NeoCoil participates in E-Verify.

Contact Information

If you are interested in joining a growing organization with a vision for the future, please send us your resume. We are a fast-paced work environment, offering competitive compensation, family-friendly benefits and so much more. Please visit *************** for more information. Interested applicants should submit a cover letter and resume, including salary requirements, to ***********************

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