Radiant Systems Inc · 3 hours ago
Senior Quality Engineer
Radiant Systems Inc is hiring a Senior Quality Engineer to join their Quality Engineering team. The role involves collaborating with R&D and Manufacturing teams to develop tools and processes that address quality and compliance challenges, while leading various quality improvement initiatives.
Responsibilities
Identify and solve complex problems in a multi-stakeholder, team-based environment where precedent may not exist, using creativity while maintaining compliance with industry regulations
Manage cross-functional projects, timelines, and budgets; implement digital quality tools (eQMS, dashboards)
Translate technical information to all levels of the organization through large and small presentations
Independently lead QMS improvement activities and associated projects
Own and perform documentation changes and establish policies and standards followed by others
Lead CAPA execution, root cause investigations, and quality data analysis to identify trends
Own and drive validation testing (all types), TMV, and software validation testing
Lead identification, development, and optimization of complex manufacturing processes using engineering methods (e.g., Six Sigma and Lean tools) for design for manufacturing and continuous process improvement
Identify opportunities and implement solutions for redesign/design of complex equipment, new technologies (including automation and software), tools, fixtures, etc., to improve manufacturing processes and reduce risk
Drive development and execution of complex experiments and tests (including writing and executing protocols) to validate and improve processes; ensure completion of process validations (IQ/OQ/PQ), analyze results, and develop reports
Qualification
Required
Bachelor's or master's degree in engineering (Mechanical, Chemical, Biomedical, Bioengineering, or other applied sciences)
6+ years of experience in medical device engineering or quality engineering roles
Ability to travel approximately 15%
Experience with statistical software (Minitab, JMP)
Preferred
Experience investigating complex manufacturing quality and compliance issues (e.g., CAPA, non-conformances, audit observations) across production processes using engineering principles; analyze results, make recommendations, and develop reports
Certified Quality Engineer (CQE) or equivalent
Strong knowledge and hands-on experience with measurement and test equipment
Process validation experience
Comprehensive expertise in Quality Engineering principles and applications (CQE body of knowledge)
Proficiency with quality tools such as FMEA, CAPA, and statistical analysis
Company
Radiant Systems Inc
Radiant Systems, Inc. is a certified Minority Business Enterprise, a Global Consulting company founded in 1995.
H1B Sponsorship
Radiant Systems Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (3)
Funding
Current Stage
Late StageCompany data provided by crunchbase