Quality Engineering Senior

1st Shift: Work days/hours: Client: Medical Device Company

No H1b’s

Locals only, must be able to go to the office at least 2X/week

Quality Engineer

Duration: 12+ Months contract

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Overview Quality Engineering is responsible for product and service quality evaluation and control. The Engineer is involved in resolving the equipment and process‑related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured. Demonstrates intermediate knowledge of quality engineering policies, principles and best practices. Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity. Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision. Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended.

Requirements Sound workable knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2015 and ISO 13485:2016

Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity

Ability and skill to lead or manage process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC Six sigma, additionally root cause analysis and project management techniques are routinely employed

including associates, managers, peers and customers when making decisions and solving problems

Experience with complaint investigation

Experienced in Microsoft Office suite skills. Basic mini tab and/or related analytical software programs

BS in related field required with minimum of 3 years of Quality Operations or Regulatory experience in the medical device environment or 5 years in manufacturing environment or MS with 3 years of experience. Typical degree in Mechanical or Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field. Experience and understanding of electro‑mechanical instrumented systems. Professional certifications such as Certified Quality Auditor/Certified Quality Engineer, Six Sigma preferred.