Senior Quality Engineer ( Software focus)

Aspect Medical Systems is a global market leader in brain monitoring technology.  To date, the companys technology has been used to assess over 14 million patients and has been the subject of over 2300 published articles and abstracts.  The companys technology is installed in over 70% of US hospitals in the July 2005 US News and World Report ranking of Americas Best Hospitals and in 45% of all US operating rooms.  The technology is available in more than 160 countries. The company is public and headquartered in Newton, Mass. 

 

 

JOB TITLE:  SENIOR QUALITY ENGINEER (Software focus)  Aspect Medical Systems

 

Plan, coordinate and support quality programs designed to maximize product reliability and minimize costs while maintaining regulatory compliance.  Ensure product integrity by participating in software design verification and validation activities for product embedded software and software used in support of manufacturing equipment and quality systems  Collaborate with Manufacturing, Engineering, Marketing and Quality Systems to improve product quality.

 

RESPONSIBILITIES:

 

 

Participate on new product development teams as the quality representative for implementing new products into manufacturing.  This would include participating in design and process FMEAs, risk management activities and developing quality plans.

 

Participate in s/w verification and validation activities within the Product Development process.

 

Participate in software validation / revalidation of software used in manufacturing processes or in support of quality systems.

 

Analyze internal and external quality data including manufacturing yields, supplier performance, complaints, etc. to help identify and drive corrective and preventive actions required to improve product and process quality.

 

Support product complaint investigations that may be software related

 

Plan, promote and organize training activities related to product quality and reliability.

 

Participate in the selection of suppliers, and implementing and monitoring supplier quality improvement goals.

 

Conducts root cause analysis for product quality issues or in support of Corrective / Preventive Actions.

 

Create, review and approve quality-related documents; Inspection Instructions, First Article Inspections, SOPs, Work Instructions, etc.

 

Process & Product ComplianceEnsure that processes and products are compliant with customer and internal quality requirements.Communicate with manufacturing and engineering to recommend changes to inspection methods, designs, tooling and processes to promote continuous improvements.Maintain FDA Quality System Regulation and ISO 13485 Quality System compliance at all times, including the following all SOPs.Participate in product support process and monitor production and post-production risk management feedback.

QUALIFICATIONS / SPECIAL SKILLS:

 

Bachelors Degree in Software, Computer or Electrical Engineering or equivalent education or experience.

 

5 - 8 years related quality experience preferably in the Medical Device field.

 

Experience in s/w bug tracking and source code control tools.

 

Thorough knowledge of principles of product and service quality evaluation, auditing techniques for FDAs QSR and ISO 13485 standards, and manufacturing processes and procedures.

 

Working knowledge of ISO 14971 Risk Management.

 

Strong knowledge of product testing, verification and validation methodologies.

 

ASQ Certified Quality Engineer (CQE) highly desirable.

 

Certified Six Sigma Black Belt would be a plus.

 

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