Quality Manager - Medical Device
Harwood Heights, IL 
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Posted 21 days ago
Job Description

Dabir Surfaces, a Methode Company, is seeking a Quality Manager to manage the team responsible for inspection and testing of materials, parts, and products to ensure adherence to established quality standards.

Headquartered in Chicago, Illinois, Dabir Surfaces Inc. is focused on improving patient outcomes and preventing pressure injury (ulcer) through the design and manufacture of advanced medical device technologies. To learn more, visit dabir-surfaces.com.

Methode requires all new hires to be fully vaccinated against COVID-19 but will make reasonable accommodations for those who cannot receive a COVID vaccination due to a disability, a religious reason, or pregnancy.


Responsibilities:

  • Ensure project/department milestones/goals are met and adhere to approved budgets

  • Manage subordinate staff in the day-to-day performance of their jobs

  • Develop, coach, and mentor direct reporting Quality team members

  • Assess training needs and provide training to Quality and Production employees

  • Manage customer return process

  • Resolve and work supplier quality

  • Recommend new or improved quality control methods, procedures, and/or standards

  • Develop, modify, apply, and maintain quality evaluation and control systems and protocols for processing materials into partially finished or finished product

  • Responsible for quality NPD functions, change control, process improvement, supplier, and CAPAprojects

  • Oversee the planand executionto mitigate product and process risks identified through the risk management process and establishedprocedures, including but not limited torisk analysis, DFMEA,PFMEA, Fault Tree Analysis, etc.

  • Collaborate with Engineering Laboratory and Production functions to ensure quality standards are in place

  • Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment

  • Utilize quality tools to help drive continuous improvement

  • Maintain a working knowledge of government and industry quality assurance standards

  • Other duties as assigned

Qualifications:

  • Bachelor's degree in Engineering or related field

  • 5+ years of medical device industry experience in a Quality role with some leadership experience

  • FDA regulated medical device industry experience required; high-volume manufacturing experience preferred

  • Strong knowledge of medical device design control and risk management processes and regulations, including software as a medical device. - e.g., 21CFR Part 820, ISO14971, ISO13485, IEC62304, EU MDR, etc.

  • Certified in lean and six-sigma quality methodologies

  • Ability to clearly identify problem areas and communicate problems to engineers and Operations that could include customer representatives.

  • Experience creating and executing practical solutions to product problems in a manufacturing environment

  • Ability to create Engineering Guidelines for use in design development

  • Capability to multitask and manage multiple projects

  • Ability to travel to supplier locations as needed

  • Must be fully vaccinated against COVID-19, if not currently employed by Methode Electronics, Inc. (subject to reasonable accommodation for those who cannot receive a COVID vaccination due to a disability, a religious reason, or pregnancy)

Methode Electronics is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, genetic information and other legally protected characteristics. The EEO is the Law poster is available here: EEO Poster, if you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to recruiting@methode.com or call (708) 867-6777 and let us know the nature of your request and your contact information.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
5+ years
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