Principle Quality Engineer

Kforce Technology Staffing
Germantown, MD
30 Sep 2024

Vacancy expired!

RESPONSIBILITIES:Kforce has a client that is seeking a Principle Quality Engineer in Germantown, MD.

Duties Include: Principle Quality Engineer will manage compliance to FDA quality system regulations, ISO 9001/13485 requirements and European Medical Device Regulation (MDR) Ensure all aspects of the quality system are maintained and monitored for continuous improvement Assist in the development and compliance of the CE Design Dossier Assist in the development and submission of PMA applications Implement an ongoing management of Company Wide ISO/ GMP quality systems including but not limited to CAPA, non-conformances, internal audits, customer complaints & deviations As a Principle Quality Engineer, you will be responsible for assigning NCRs, participating on the MRB, and tracking NCRs to completeness Participate as member of Internal and/or External Audit team Responsible for scheduling, performing, and reporting internal audits and related activities Manage all manufacturing activities Principle Quality Engineers manage Risk Management file Lead the Design Reliability, Characterization, and Verification test activities

REQUIREMENTS: Bachelor's degree required; Degree in Engineering or related field preferred Minimum 10(+) years in a Quality Department regulated industry with 3-5 years in Quality Manager position Preferred to have ISO 13485 auditor training/ certifications, CAPA training/certification and good experience in process validation Must have knowledge of root cause analysis, corrective/preventive actions, and process improvement Must be skilled in use of Microsoft Office Word, Excel, PowerPoint Must demonstrate highly developed communication skills including well developed writing skills and verbal and interpersonal skills Ability to organize tasks, work independently and adapt to changing priorities Ability to function in a minimally supervised environment with exceptional attention to detail required Extended work hours may be necessary to meet business demands May require travelling to supplier sites (25%)

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
  • ID: #46110076
  • State: Maryland Germantown 20876 Germantown USA
  • City: Germantown
  • Salary: Competitive
  • Job type: Permanent
  • Showed: 2022-09-30
  • Deadline: 2022-11-27
  • Category: Et cetera