Overview

 SUMMARY OF POSITION:

Provide quality engineering support in design and development of medical device products, specifically ventilators. Facilitate the application of design controls in product development and sustaining changes. Provide support in the rapid resolution of product complaints and/or safety issues.

 

ESSENTIAL FUNCTIONS:

  • Review new and modified product designs for quality characteristics, including     manufacturability, serviceability, testability, reliability, and product requirements.

  • Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations.

  • Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous and feasible product requirements that support the market needs

  • Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).

  • Partner with Software Engineering to assess risk, develop software design plans and documentation, ensure code and integration reviews occur, and to demonstrate software capability and maturity.

  • Assist in the creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.

  • Provide guidance and direction for sample size and statistical analysis of verification and validation test results.

  • Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.

  • Provide training to project teams on procedures, verification, validation, statistical methods and design controls.

  • Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report

  • Review Design History Files and Technical Files for conformance to applicable requirements

  • Assist, when appropriate with internal and supplier audits.

  • Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues.

  • Provide support to the Regulatory Department in writing technical submissions.

 

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

  1. Adheres to the competencies and skills for the specified position as defined in the Quality Professional Leveling Matrix.

  2. Other duties as assigned with or without accommodation.

 

MINIMUM REQUIREMENTS:

Education / Experience:                 

  • BS with 5-8 years

Desirable but not essential:

  • MS with 3-5 years

  • PhD with 0-3 years

Skills/Qualifications:    

  • Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.

  • Good verbal and written communication skills including protocol / report development and technical presentations.

  • Risk Management, ISO 14971, FTA, FMEA, HACCP.

  • Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis.

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