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Reference # : 18-00716 Title : Associate Quality System Specialist
Location : Northridge, CA
Experience Level : Start Date / End Date : 02/12/2018 / 02/11/2019  
Company: Artech Information Systems
Job Title: Associate Quality System Specialist
Location: Northridge, CA
Job ID: 18-00716
Duration:12 months

This Role will support coordination and completion of the Quality Management System (QMS) updates required to meet the requirements of the new European Union Medical Device Regulation (MDR).

Careers That Change Lives
This position is an individual contributor role in the Quality System department. The primary responsibility of this position is to facilitate the transition to the new European Medical Device Regulation (MDR). This position will interact with Regulatory, and other departments to ensure process changes are implemented correctly by implementing, improving and executing policies and procedures.

This role resides in the Diabetes Quality Administration Department and serves as liaison to the global EU MDR transition team. Through this relationship this person will receive the tools, training and support necessary to ensure that the practices he/she is following at the local site are in line with global Healthcare practices.

The Associate Quality Systems Specialist will be responsible for leading and/or supporting projects that impact the Quality System and help achieve the desired improvements.

A Day in the Life
  • You will manage the Quality System EU MDR transition plan and its improvements, maintaining current state process maps and procedures
  • You will assist Regulatory Project Manager tracking process improvements across the Quality System
  • You will train employees on current and new processes
  • You will identify, in conjunction with leadership, process deficiencies and opportunities and recommends solutions.
  • You will lead and monitors other projects with low to moderate scope and complexity from initiation to successful completion as defined by leadership
  • You will identify and work to remove barriers that slow or prevent the successful completion of projects assigned to. Enlists leadership actively and as needed to assist with barriers.
  • You will proactively reach out to subject matter experts for knowledge, benchmarking and assistance to ensure projects are successful
  • You will communicate with internal and external project stakeholders with regular cadence through a variety of mediums, including presentations, email and stretches on project status and performance. Ensures that stakeholders have up-to-date information needed for their function, in a timely manner.
  • You will document and analyze information and data as needed to make projects successful.
Must Have:
To be considered for this role, the following minimum requirements must evident on your resume.
  • Bachelor's Degree and 1+ year of work experience or Master's Degree and internship/work experience.
  • Familiarity with Quality Management System Regulations.
  • Experience with document control management within the regulated industry
  • Microsoft Office: including Excel, Access, Word and Outlook
  • Travel up to 10%
Nice to Have
• Understanding of EU MDR
• DMAIC, Lean/Six Sigma knowledge and Process improvement
• Analytical skills and experience in data scrub using different tools including: Microsoft Office including Excel, Project, Access, PowerPoint, Word and Visio
• Ability to work effectively in a cross functional team environment and build strong working relationships.
• Ability to work well under pressure and maintain positive, enthusiastic attitude in a fast-paced environment
• Good interpersonal skills and strong communication skills, both oral and written
• Demonstrated ability to communicate professionally, both via written and verbally
• Skilled in influencing and partnering with others, both inside and outside department
• Eagerness to learn and expand responsibilities as there may be specific education, experience orskills based on the departmental needs

Rajiv Maruthi
Artech Information Systems