Quality Engineer
JOB DESCRIPTION
Description :
Currently seeking a Quality Engineer to join our Medical Device Manufacturing team.
Skills :
Quality engineering, Quality assurance, Medical device
Top Skills Details :
Quality engineering,Quality assurance,Medical device
Additional Skills & Qualifications :
Requirements :
Bachelor of Science Degree in Engineering or Related Science Field (or equivalent experience)
Minimum 3+ years of experience in the Quality Assurance field working with ISO , FDA Quality System Regulations, and Medical Device Directive requirements.
Minimum 1 year utilizing corrective and preventive action (CAPA) system, in compliance with US federal and international regulatory standards relating to medical devices.
Minimum 1 year experience in Nonconforming Product Management.
Minimum 1 year experience in Complaints investigation.
Minimum 1-year Utilization of root cause analysis tools, including fishbone diagrams, fault tree analysis, 5 Whys, Is / Is Not.
Process validation; statistical process control, root cause investigation, and use of problem-solving tools.
Basic knowledge of Lean Manufacturing and Continuous Improvement concepts and tools.
Preferred Qualifications :
Experience working in an electro-mechanical assembly manufacturing environment.
Specialized Training : FDA GMP training; Basic statistical including trends, pareto and other basic charting techniques.
Training with basic statistical including trends, pareto and other basic charting techniques.
Desirable Lean Six Sigma Green Belt Certification.
Experience Level : Expert Level
Expert Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market.
With a network of almost 30, consultants and more than 4, clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune .
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through :
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options.