Open Position: Associate
Function: Quality Engineering
This individual will contribute their technical skills to the development and maintenance of medical devices and combination products. Supports the Quality lead on product development teams and laboratory testing activities.
Please send your resume and a cover letter to [email protected] and include Associate, Quality Engineering in the Title.
Essential Duties and Responsibilities
- Contributes to product development deliverables (i.e., Risk Assessments, protocols/reports, and other Design History File documents) for client specific projects
- Participates in product development activities
- Supports the Quality review of laboratory documentation, including testing protocols and reports
- Supports Quality activities related to maintenance of the EdgeOne Medical testing laboratory
- Supports internal and external audits, observations, responses and applicable certifications
- Assists in the preparation of data feeders including but not limited to internal and external audit observations, CAPA’s, process behavior trends, customer feedback, and management review to determine effectiveness of the quality system
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- Bachelor’s degree in Engineering, Life Science, or Equivalent
- 2-3 years of experience in a quality function or engineering (product development)
- Familiarity with ISO 14971, ISO 13485, and 21CFR820
- Self-starter and collaborative team player
- Strong multi-tasking and communication skills
- Motivation and desire to share your knowledge with the broader industry community
- CQE certification in process or attained.
- Project management skills – desired.
Equal Employment Opportunity
Discrimination in hiring, promotion and all other employment decisions on the basis of race, color, religion, gender, national origin, age, disability, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other basis protected by Federal, state or local laws is prohibited.