Quality and Regulatory

Job Description:

This position offers an exciting opportunity for professional growth and contribution to help improve the lives of congestive heart failure patients. We are looking for a highly motivated individual to join our team.  The selected candidate will work with team members to oversee the full life cycle of medical device development. The successful candidate will work closely with product development and extended teams to help streamline our quality management systems. This position will be reporting to Director of Quality and Regulatory.

Duties and responsibilities:

• Work with cross-functional team to streamline design documentation for regulatory submissions.
• Quality and Regulatory documentation consists of design specifications, manufacturing procedures, test methods, specification, and manufacturing drawings and other per quality and regulatory requirements.
• Actively work with engineers with equipment assembly and execution of installation and operational qualifications
• Work with team members to improve quality and characterization test reports.
• Perform troubleshooting and root cause analysis.
• Work with engineers to perform hazard and risk analysis, prepare necessary documentation.
• Work within the cross-functional team to develop test protocols and final reports.
• Communicating test results concisely and in a timely manner
• Perform other project tasks as assigned.

Qualifications:

• Excellent written and verbal communication skills
• Strong teamwork and organizational skills
• Ability to work cross-functionally with Electrical, Mechanical, Software, and Quality teams.
• A self-starter, ability to complete assignments in a timely manner.
• Ability to work independently with minimal daily oversight.
• Knowledge of statistics and statistical tools is preferred.

Other:

• Prior medical device industry experience is preferred, but not required. 
• Individuals must have strong organizational skills and is willing to learn and develop.
• An engineering degree is preferred or progressing towards completing education.