SOFTWARE QUALITY ENGINEER

Position Summary:

Responsible for ensuring that the software used as part of   our medical devices and products is developed according to good design practices and follows the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies.   Provide leadership, oversight and training to division manufacturing plants for computerized system validation.   Translate quality standards into processes and procedures and apply these to the design process.

Minimum Requirements:

Bachelor of Science degree in Electrical Engineering, Computer Science, or Computer Engineering

3+ years in a software quality engineering or software test role dealing with software that is part of a medical device, or a product for a highly regulated industry i.e. aerospace, automotive, etc.

Working knowledge of product risk assessment, requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle

Understanding of current Software Quality techniques and software industry standards (e.g. ISO, IEEE, CMMI), and their impact on internal procedures, software quality, safety and efficacy of products

Working knowledge of C, C++, and LabVIEW

Understanding of the FDA Quality System Regulation, ISO 13485, and Medical Device Directive a plus, not required

SR. QUALITY ENGINEER

Position Summary:

Provide quality engineering support in the design and development of medical device products, and facilitate the application of design controls.   Translate Quality Standards into processes and procedures and apply these to the new product design process.

Minimum Requirements:

Bachelor of Science degree in an engineering discipline, EE preferred

5+ years of quality engineering experience in a high volume manufacturing environment

Skilled in test plan development and root cause failure analysis

Skilled in statistical methods, including ANOVA, statistical process control, sampling plans, gage R&R, and design of experiments

Good verbal (including presentation) and written communication skills, especially technical report writing

Ability to effectively work on project teams

Familiar with reliability analysis and test methods

Familiar with ISO 14971 or strong e experience in risk evaluation techniques, such as FMEA and/or fault tree analysis

CQE certification desirable

DIRECTOR, CLINICAL AFFAIRS

Position Summary:

Assume management responsibility for strategic planning, design, implementation and execution of clinical programs as well as interpretation of clinical study results, preparation of study summaries and reports for regulatory filings, and presentations and publications for the Respiratory Division.

Minimum Requirements:

Bachelor’s degree in a clinical discipline (B.S.N, etc.)

10+ years working in a clinical environment and conducting clinical studies

5+ years working in the medical device industry in a management capacity

Alternatively, an advanced degree with 5 years of related clinical experience and 3 years of medical device industry experience in management will be considered.

Demonstrate advanced, comprehensive knowledge of clinical and laboratory study design and principles

Demonstrate advanced, comprehensive understanding of applicable Federal regulations, Good Clinical Practices and international standards

Demonstrate advanced oral and written communication skills

For immediate consideration please send your resume to career@q4medsource.com  or