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."
- 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.
- 21 CFR Part 820 compliance
- ISO 13485 awareness
- FMEA tools
- Engineering processes
- Vendor Assessment
- 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