Quality Engineer

Confidential Company  •  North Haven, CT

Less than 5 years experience  •  Technology

Salary depends on experience
Posted on 07/04/18 by Cynet EngineeringTeam
Confidential Company
North Haven, CT
Less than 5 years experience
Technology
Salary depends on experience
Posted on 07/04/18 Cynet EngineeringTeam

We are looking for Quality Engineer for our client in North Haven, CT

Job Title: Quality Engineer

Job Location: North Haven, CT

Job Type: Contract ? 12 Months / Contract to Hire / Direct Hire

"US citizens and those authorized to work in the US are encouraged to apply. We are unable to sponsor H1b candidates at this time."

Job Description:

  • Quality Engineer - Medical device- 21CFR820 -PPAP -Minitab 
  • Min 3 - 5 year of exp
  • The  Quality Engineer Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
  • Devices and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • May specialize in the areas of incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Domail Skill:

  • 21 CFR Part 820 compliance
  • ISO 13485 awareness

Tool Skill:

  • PPAP
  • Validation
  • Minitab
  • FMEA tools

Functional Skill:

  • Engineering processes
  • Quality
  • Vendor Assessment 

Skills:

  • 3-5 years of exepereince in Medical Quality Engineering
  • Knowledge of GMP's & applicable ISO.
  • Knowledge of ANSI standards for sampling plans and basic statistical tools. Exposure to FMEA, SPC & TQM. 
  • Relevant Quality Engineering experience in devices or similar regulated environments. 
  • Demonstrated ability to effectively prioritize and accomplish work with minimal supervision. 
  • Strong knowledge in CAPA system, investigations, Quality Tools, Six Sigma, Continuous Improvement and 
  • problem-solving skills. 
  • Process and equipment qualificationexperience in an FDA regulated environment. 
  • Process Engineering or Manufacturing Engineering experience preferable.
  • Experience in Medical Device highly desirable. 
  • Able to work with minimum supervision. 
  • Knowledge and comprehension of mechanical drawings. 
  • Executes quality engineering deliverables required by the Product Development Process. 
  • Participates in developing master test plans that encompass design verification, design validation and process validation activities. 
  • Author & review validation (IQ/OQ/PQ) protocols and reports to ensure compliance to regulatory requirements and quality objectives. 
  • Participates in supplier selection process and specification reviews
  • Engineering support and guidance in component measurement and Geometric Dimension &Tolerances 
  • Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices 
  • Prepare SCRs and review PPAP documentation (Control plan, PFMEA, PFD
  • Statistical Result analysis,MSA
  • Experience with data analysis/statistical such as MiniTab or equivalent  
  • Green/Black belt preffered
  • Ability to perform all assigned tasks, work independently, and complete work on schedule
  • Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization
  • Strong problem solving skills and efficient management of time and resources 

Education:

  • BE/BS

Industry:

  • Medical

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