This medical device company is developing two devices with capabilities to deliver medication to the brain and/or aspirate cerebrospinal fluid from the brain ventricles. Under the direct supervision of the Vice President of Quality, Clinical and Regulatory Operations, the Quality Engineer works with cross functional teams to execute direction for the company’s Quality compliance requirements on new and existing devices. This position is responsible for the day to day execution of all Quality System requirements to stay ISO/QSR compliant.
To perform this job successfully, an individual must be able to perform each essential function satisfactorily:
- Support the development of the Company’s quality objectives, and will work in conjunction with the company employees to ensure ISO/QSR compliance.
- Participate in regulatory and quality audits as required to maintain ISO/QSR compliance.
- Collaborate with internal and external partners e.g. laboratories, manufacturers, packagers, to provide medical devices that meet quality requirements for new and existing products.
- Work with product development and operations to design and produce labeling, instructional and promotional materials that are in compliance with quality requirements.
- Perform all administrative activities associated with the department. This will include supporting the department’s goals and objectives.
- Actively comply with Company's Quality System.
- Company is a start up entrepreneurial environment and each employee may be asked to assist in work in areas outside of their usual duties. This is an expectation of each employee.
Education and Experience:
Four-year degree in biomedical engineering or related engineering degree. Related work experience in the medical device field or related industry for the following levels:
- Associate: 0-3 years
- Engineer: 2-6 years
- Senior: 5-9 years
- Principal: 7+ years
Skills and Abilities:
The ideal candidate will possess the following qualifications:
- Excellent verbal and written communication skills.
- Team-oriented individual with strong interpersonal skills, management and leadership skills
- Strong leadership, excellent organizational skills, and a good blend of discipline and creativity.
- Solid analytical skills and the ability to problem solve quickly.
- Commitment to company with ability to function within a start-up environment.
- Skilled in Microsoft Office (Word, Excel, PowerPoint, and Outlook).
- Understanding of FDA requirements and ISO 13485.