Quality Systems Engineer - Medical Devices ISO 13485

Employment Type

: Full-Time


: Healthcare - Allied Health

QUALITY SYSTEMS ENGINEER - ISO 13485 We are looking for an experienced Quality Systems Engineer for a 3-6 month assignment in Southwest Houston. In this role you will be responsible for ensuring that the Quality Management System QMS is properly constructed and kept up to date with current applicable Global Standards. This is primarily achieved by providing support to the development of high level policies and guidelines which the site then adopts and adheres to. DUTIES AND RESPONSIBILITIES:

  • Interpret FDA, ISO, CSA regulations and develop company compliance that satisfies ISO 9001:2000, ISO 13485, the Canadian Medical Device Regulations, and the U.S. FDA cGMP/QSR.
  • Responsible for routinely reviewing and updating processes and procedures with respect to the scope of operations to ensure the site remains compliant with any applicable standards and that the documented processes and procedures are properly updated, implemented and adequately understood throughout the facilities workforce
  • Maintains up to date knowledge of current and emerging Global Regulatory requirements affecting the business and to make decisions regarding actions necessary to obtain or maintain compliance with applicable regulations FDA/ISO/Third Party/Internal and Supplier Auditing
  • Oversee the practice of systematic audits in relation to requirements found in ISO: 13485: 2003, the FDA Quality System Regulation and any other applicable requirements.
  • Facilitate the definition, assignment and closure of corrective actions.
  • Report audit results and corrective action progress to management.
  • Organize ongoing preparedness activities in anticipation of routine external audits by FDA, Notified Bodies, and other regulatory agencies.
  • CAPA System support - Monitoring CAPA/SCAPA timelines to ensure that CAPA projects do not become overdue, Trending of CAPA data, Assigning individuals or ensuring a team is formed to non-conformances. Partnering with impacted groups to determine root cause s during CAPA investigation. Tracking and ensuring the effectiveness of the CAPA activities, Documenting the closure of CAPA and SCAPAs.
  • Risk Management Program/Continuous Improvement - Ensure that the QMS continues to evolve as compulsory regulatory requirements are revised, updated and newly created. Regularly advise Management, through direct communication and special reports, of significant events or issues which could have a substantial effect positive or negative regarding compliance levels.
  • Post Production Monitoring Risk Management Creation of post-production risk assessment reports.
  • Quality Systems Training - Provide Quality Management System training.
  • Complaint Investigations - Initiate Complaints, Ensure that the complaint is thoroughly investigated, Documenting results of investigation in SAP., Notification to Regulatory for final review and closure of complaint., Trending customer complaint in an effort to identify trends and determine if additional process review or corrective action is required.
  • Non-Conformance Program - Lead/Facilitate Material Review Board MRB Change Management, Lead Change Control Board CCB Reviewing the content of all change requests and supporting documentation for accuracy., Evaluating the impact of the change. Verifying justifications for extensions. Releasing the Engineering Change Order Supplier Evaluation, Partnering with PDI and Production Operations to approve new suppliers.
  • Environmental Compliance - Creation, implementation and maintenance of the Environmental Management System for the facility.


  • Knowledge of FDA's Code of Federal Regulation, ISO 13485, Japanese MHLW Ordinances, Medical Device Directive, and other Global Standards and Requirements pertaining to medical devices in general, and more specifically, to QMS, CAPA, Internal Auditing, Continuous Improvement and Supplier Development.
  • Ability to read and intetpret regulatory/legal documents and determine the required compliance activities.
  • Ability to collaborate with other professionals (including FDA personnel, consultants, physicians).
  • Verbal and written communication skills including ability to proof read, edit, and/or write procedures in clear, concise language.
  • Ability to multi-task and to solve problems.
  • Organizational and time management skills.
  • Must be able to maintain productive working relationships with co-workers.
  • Ability to adapt and demonstrate flexibility in dealing with changing priorities and work situations.


  • A minimum education level of a Bachelor's Degree in Life Sciences, Quality Engineering, Regulatory Affairs, or other discipline with an established curriculum related to Quality Management Systems and Regulatory Requirements.
  • Five years of medical device or pharmaceutical experience preferred.
  • Technical background sufficient to understand devices and medical procedures so that devices and procedures can be explained to FDA and other regulatory bodies.

Why Kelly?

As a worker today, it s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what s next is what we re all about. We know what s going on in the evolving world of work just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

About Kelly

At Kelly, we re always thinking about what s next and advising job seekers on new ways of working to reach their full potential. In fact, we re a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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