Open Position: Manager
Function: Quality Engineering
Contributes their Quality technical and analytical skills to the successful development and maintenance of medical devices and combination products. An integral member of the development team—will be interacting with teams involved with FDA, CE Mark, and CLIA compliance issues involved with product development cycle and its impact on the post market requirements.
Please send your resume and a cover letter to [email protected] and include Manager, Quality Engineering in the Title.
Essential Duties and Responsibilities
- Lead and actively contribute to quality related product development deliverables (i.e., Risk Assessments, protocols/reports, and other Design History File documents) for client specific projects
- Participates in product development activities and oversees completion of deliverables
- Responsible for Quality review of laboratory documentation, including testing protocols and reports
- Responsible for Quality activities related to maintenance of the EdgeOne Medical testing laboratory, including oversight of equipment calibration
- Participate in internal and external audits, observations, responses and applicable certifications
- Participate in the coaching, training and mentoring of both EdgeOne employees and Clients on quality engineering product development requirements and processes that impact regulatory filings, the quality system or client product
- Assist in the review 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
- Partner with suppliers in providing necessary services to the client
- Develop client relationships and personnel commensurate with their job responsibilities
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
- 5-7 years of experience in quality function related to medical devices with CQE certification
- Thorough understanding and experience with ISO 14971, ISO 13485, and 21CFR820
- Broad knowledge of the Product Development Processes and its supporting quality systems
- Strong leadership, facilitation, mentoring, and communication skills
- Strong multi-tasking and project management skills
- Must be able to interact and communicate with all levels of an organization
- Must be able to interface with clients on a personal level
- Motivation and desire to share your knowledge with the broader industry community
- Experience with supporting the development of a device from concept through launch
- Experience with development of combination products is desired.
- Project management experience is desired.
- Software experience 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.