Quality Engineer PM Consultant (2 Openings)

job summary:

• Ensure software development and V&V processes meet quality and regulatory requirements of FDA and ISO
• Provide ongoing software quality engineering support throughout the product software life cycle by participating in Software development reviews, code reviews and formal software technical reviews
• Review new and modified product designs for quality characteristics, testability and traceable to product requirements.
• Review verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.
• Review Design History Files and Technical Files for conformance to applicable requirements
• Assist, when appropriate with internal and supplier audits.
• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
• Contribute to software life cycle process improvements
• Responsible for validating Non-Product Systems Software
• Create all required documents for Non-Product Systems Software
• Provide support on Non-Product Systems Software for various groups within the business

• Experience with test methods and standards for the design, verification, and validation of medical device products with emphasis around software development/testing.
• Understanding of Object-Oriented Programming
• Experience with analyzing data from SQL databases and writing SQL queries
• Understand the processes and intent of all aspects of the QMS related to Design Controls
• In-depth knowledge of and auditing experience to the 21CFR820, ISO 13485, IEC62304 and the Medical Device Directive.
• Skilled in test plan development and root cause/failure analysis.
• Good verbal (including presentation) and written communication skills, especially technical report writing.
• Ability to effectively work on project teams.

• Other duties as assigned with or without accommodation.

• 3-5 years of software quality engineering experience or equivalence.

• Familiarity with regulatory requirements e.g. IEC 62304, ISO 13485, 21 CFR Part 11, GAMP, 21 CFR 820 & ISO 14971.
• Experience in risk evaluation techniques, such as DFMEA & Product Risk Assessment.
• ASQ CQE, CSQE certification desirable, but not essential.
• National Instruments TestStand, LabVIEW knowledge and experience highly desirable
• Experience with Software Reliability is desireable

• BS in Software related disciple or equivalent work experience.

• This position functions in an environment that requires the ability to interface with standard office equipment such as computers, printers, copiers, fax, telephones, etc. Position will spend periods of time sitting, standing, walking, etc., as part of the normal conduct of daily business affairs.
• Lifting up to 25 lbs

• Ensure software development and V&V processes meet quality and regulatory requirements of FDA and ISO
• Provide ongoing software quality engineering support throughout the product software life cycle by participating in Software development reviews, code reviews and formal software technical reviews
• Review new and modified product designs for quality characteristics, testability and traceable to product requirements.
• Review verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.
• Review Design History Files and Technical Files for conformance to applicable requirements
• Assist, when appropriate with internal and supplier audits.
• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
• Contribute to software life cycle process improvements
• Responsible for validating Non-Product Systems Software
• Create all required documents for Non-Product Systems Software
• Provide support on Non-Product Systems Software for various groups within the business

• Experience level:
• Minimum 3 years of experience
• Education: Bachelors

• Quality
• SQL
• Quality