PURPOSE AND SCOPE

As a key member of the Software Quality Group, the incumbent will support the process development activities related to the design, development, or reliability of Fresenius Medical Care’s products.

PRINCIPAL DUTIES AND RESPONSIBILITIES

Familiarity with the FDA’s Quality System Regulation (QSR) 21 CFR Part 820.

Understanding of ISO13485 (Medical devices – Quality management systems) and ISO 14971 (Application of risk management to medical devices)

Knowledge of QMS principles and practices

Expertise in risk management processes, including hazard analysis, risk assessment, risk control

Understanding of design control processes, including design input, design output, design verification, design validation, design transfer, and design changes

Strong problem solving and analytical skills.

Lead major efforts, or phases of projects, to resolve Software Quality-related problems

Support the product development teams in the adoption and use of best practices, Quality tools, and Software Design Control methodologies

Develop and execute systems level and functional area tests

Monitoring and developing software reliability improvements to existing & new design

Strong analytical and problem-solving skills, ability to multitask in an environment with changing priorities

Support Software Quality System sub-systems as directed by senior management, i.e. CAPA, Internal Audits, et

Assist with various projects as assigned.

Other duties as assigned.

EDUCATION

Bachelor's Degree required; Advanced Degree desirables

REQUIREMENTS

7+ years related Software Quality Assurance/Quality Engineering experience.

4+ years experience with embedded software or real-time devices/systems level testing required

2+ years experience leading and managing software quality teams

ASQ Certification(s) a plus, Six Sigma experience highly desirable

Working knowledge of FDA Quality System Regulation 21 CFR Part 820 and ISO13485 required.

Excellent verbal communication and technical writing skills

Ability to interface with multiple groups in the organization.

Experience with structured programming languages and scripting desired

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.