Open Position: Manager, Quality Engineering

Function:  Regulatory Affairs/Quality Assurance (RA/QA)

Summary

EdgeOne Medical is seeking a Quality Engineering expert to join our growing Quality organization. This role is responsible for leading or overseeing quality efforts for laboratory activities including equipment qualification, test method development and validation, and testing. Additionally, this role will support or lead quality efforts for various device and device combination product development programs.

Please send your resume and a cover letter to careers@edgeonemedical.com and include Manager, Quality Engineering in the Title.

Essential Duties and Responsibilities

  • Contribute to product development design control deliverables (i.e., planning documents, risk management, 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 Engineer review of laboratory documentation, including protocols and reports for test method validation (TMV), design verification/validation testing as well as equipment and software qualifications
  • Responsible for Quality activities related to qualification of EdgeOne Medical testing laboratory
  • Support 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
  • Partner with suppliers in providing necessary services for EdgeOne activities
  • Develop client relationships and personnel commensurate with their job responsibilities

Qualifications

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 years of experience in a medical device quality role supporting product development or testing and TMV
  • 3 years of experience in a decision-making role for device design development, testing or TMV
  • 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
  • Proficient with direct interacts/communications with all levels of an organization
  • Motivation and desire to share your knowledge with the broader industry community
Preferred Experience:
  • Experience with supporting the development of a device from concept through launch
  • Experience with development of combination products with a device constituent
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.