Sr. Quality Engineer

Total Hours/week: 40.00

1st Shift: Work days/hours: M - F 8am - 5pm

Client:
Medical Device Company

No H1b’s

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

Sr. Quality Engineer

Location:
Franklin Lakes, NJ

Duration: 12+ Months contract

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

Quality Engineering is responsible for product and service quality evaluation and control. Works cross‑functionally in the development and or maintenance of products or services. 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.

Demonstrates intermediate knowledge of FDA/ISO requirements. Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity. May act as mentor to less experienced team members. 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.

• 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 effectively manage multiple tasks and drive execution of change management plans
• 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
• Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
• Ability to speak with clarity and express points of view in a variety of settings; one‑on‑one interactions, group meetings, and formal presentations
• Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems
• Experience with complaint investigation
• Professional certification preferred. Six Sigma, ASQ, AAMI
• Experienced in Microsoft Office suite skills. Basic mini tab and/or related analytical software programs
• Preferred:
  Certification such as ASQ-CQA/CQE, AAMI, Six Sigma or a Company certification such as Green Belt, Black Belt, IGQA auditor.
• 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.
• Has in-depth experience, knowledge and skills in own job family.
• Applies knowledge and skills to a wide range of standard and non‑standard situations Works independently with minimal guidance
• Usually determines own work priorities
• Acts as a resource for colleagues with less experience