Quality Engineer

Location: Charlotte, NC
Date Posted: 01-15-2018
Essential Functions:

To provide Quality Systems support to the North Carolina Quality team in order to ensure regulatory compliance and effectiveness for the BSN US LM and to provide similar support to Global Quality Management.
  • Leads and supports receiving acceptance activities for BSN US LM purchased products working closely with the BSN Quality team and Procurement to ensure compliance with FDA and ISO regulations and BSN quality system requirements.
  • Leads the Quality team in US LM BIFG NPD and change projects to ensure business, goals, quality performance and regulatory requirements are met.
  • Leads the supplier QRB team and its activities by managing quality data and CAPAs related to those products and presenting it to the board for review and input.
  • Works closely with Marketing on all US LM BIFG product issues and activities. 
  • Creates, improves, and refines supplier control documentation, such as delivery specifications, quality agreements, and supplier certifications to ensure quality system compliance and to protect BSN’s interests in supplier transactions.
  • Performs complaint investigations, provides testing and evaluation support, and writes customer response letters as may be required by the US Quality team. 
  • Performs internal quality system audits, supports corporate and supplier audit plans as required.
  • Identifies quality systems training needs for receiving inspectors.  Creates training materials and delivers or coordinates delivery as appropriate.
  • Supports the Quality Systems of the three BSN US facilities to ensure continued compliance to internal procedures and regulatory standards.
  • Supports compliance certifications by participating in external audits by customers, ISO Notified Bodies, and FDA as required.
  • Provides technical support for Quality System initiatives such as CAPA management, Complaint Handling, Training, Auditing, and Document Control to ensure compliance to regulations, efficiency in processes, and effective best practice implementation. 
  • Provides technical support and analysis for monthly quality metrics issues for both Global and for local Quality functions.
  • Identifies savings opportunities, leads and supports cost reduction/improvement activities as assigned.
Minimum Requirements/Qualifications:
  • Very good command of international quality system requirements for medical devices including QSR and ISO 13485.
  • Effective written and oral communication skills
  • Ability to effectively work with cross functional teams and provide quality systems training. 
  • Ability to work on multiple projects simultaneously.
  • Willingness to embrace and ability to execute change 
  • Good command of Microsoft Office suite of products (Word, Excel, PowerPoint).
  • Quality Systems Database design/management.
  • 3 year Quality Systems Audit (minimum ISO13485:2003 standard, prefer FDA Quality Systems Regulation standards) 
  • Minimum 4 years medical device quality assurance including specification and procedure development.
  • Engineering or Life Science related bachelor’s degree.
  • Ability to travel - domestic and international travel is required.  Travel will be performed as required to support internal audits and evaluation of external suppliers (5-10%).
  • ASQ Certified Quality Auditor  
  • Six Sigma Green Belt Certification (preferred)
  • ASQ Certified Quality Engineer (CQE) (preferred)
Additional Information:
BSN medical is an equal opportunity employer.  All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, age, status as a protected veteran, among other things, or status as a qualified individual with disability.  EEO Employer M/F/Vet/Disabled.

Applicants requiring reasonable accommodation for any part of the application or hiring process may contact at the following:

BSN Medical Attn: Human Resources
5825 Carnegie Blvd
Charlotte, NC 28209

Search Firm Representatives - Please Read Carefully
BSN medical does not accept unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or e-mails. All resumes submitted by search firms to BSN medical via e-mail, the Internet, or in any form and/or method without a valid written search agreement in place for the subject position will be deemed the sole property of BSN medical. No fee will be paid in the event the candidate is hired by BSN medical as a result of the referral or through other means.

BSN medical Inc.

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