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Compliance Regulatory Affairs Manager

Overview

Methode Electronics Inc. is seeking a dynamic individual for a position as Medical Device Compliance Manager for its Dabir Surfaces Inc. (The ?Company?) business unit. Methode Electronics is a global developer of custom engineered and application specific products and solutions with headquarters in the Chicago, IL area.? With over 5,500 employees, Methode is financially strong and extremely well positioned to grow from their existing $1.1 billion revenue.? Our focus is on design, development and manufacture of solutions for customer applications utilizing our technical capabilities in the areas of power distribution, sensors, human-to-machine interface. Further information can be found at Methode?s website: www.methode.com.? www.dabir-surfaces.com


Lead and insure that the company follows all Good Manufacturing Practices and SOP?s as defined by the Company policies, practices and procedures to insure that FDA, European Medical Device Directive, Canadian Medical Device regulations, ISO regulations and the Company quality standards are met.



Responsibilities


  • Develop and recommend plans, programs and policies required to meet established objectives, upon approval, obtain objectives for Quality Assurance by initiating and conduction periodic ?Material Review? meetings with involved Management Team Members.

  • Where applicable, inspect and evaluate manufactured goods and products during pre and post sterilization and purchased raw material and components to insure they meet quality standards established by the Company and FDA regulations.

  • Serve as designated Quality Systems Management Representative

  • Address, investigate and resolve complaints and maintain required files and records and communicate with the FDA and European Regulatory Agencies regarding potential problems with products in the field.

  • Work with customers and lead internal manufacturing groups and suppliers on quality related activities to ensure that all company APQP processes and procedures are adhered to. Insure that all records are reviewed and that standards are met prior to product release.

  • Act as the interface for the Company with the FDA during inspections and audits and for resolving and answering FDA comments.

  • Develop internal audit procedures related to manufacturing, GMP/SOP/Medical Device Directive/ISO 13485; conduct audits; and maintain records according to regulations and good business practice.

  • Responsible for Medical Device Reporting (MDRs)

  • Lead the problem solving activity and documentation for internal and external (customer and supplier) related quality issues within the Business Operating System.

  • Establish and maintain required documentation to ensure it meets requirements and applicable team members are properly trained.

  • Participates actively in design and manufacturing reviews by reviewing design prints for assigning receiving inspection criteria and for assigning critical dimensions significant characteristics (SC)and critical characteristics (CC)

  • Reviews and maintains the Quality Open Issus Deck and addresses issues with core team for timely closure.

  • Develops and initiates standards and methods for inspecting, testing, and evaluating..

  • Analyzes warranty returned parts, provides feedback to the warranty group

  • Prepare and submit 510K and other required submissions as needed.

  • Perform other duties as assigned.



Qualifications


  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Bachelor?s degree and five years? experience preferred.

  • Preferred candidates will have FDA, ISO Lead Internal Auditor, BBSS and Lean Manufacturing credentials.

  • Background in ? ISO 13485, FDA quality system regulations (US), Canadian Medical device conformity assessment (CMDCAS), and MDD 93/42/EEC (EU).

  • Advanced SPC skills and ability to read blueprints. Ability to perform root cause analysis and to apply statistics to problem solving, knowledge of techniques such DOE, Global 8D and regression analysis.?

  • Ability to communicate effectively both in verbal and written communication.

  • Must be able to travel both domestic and internationally and with short notice.

  • While performingthe duties of this job, the employees must stand, sit, bend and stoop. Have use of hands to feel and examine small parts.? The employee may be expected to move boxes and lift up to 20 pounds.? Specific vision acuities include close vision.

  • May be required to travel 20-40% of the time on short notice.


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 Click Here to Email Your Resum? or call (708) 867-6777 and let us know the nature of your request and your contact information.


 

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