- North Haven, Connecticut
- Medical Devices, Engineering, Engineering & Validation, Quality Assurance (QA), Quality Assurance (QA)
I am working with a CT based Medical Device manufacturer who are looking for a Quality Engineer on a 2 year contract.
The successful Quality Engineer will need strong problem solving, communication, manufacturing process, and leadership skills as well as Lab operations/management and some experience of Process Validation and/or Root cause analysis experience. Key Responsibilities:
- 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.
- Devises 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 design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
- Provide Quality Engineering support as a Process Validation team member and lead/execute Test Method Validations and Measurement Systems Analysis (MSA).
- Work directly with component/raw material suppliers and Incoming Quality to include inspection plan creation and maintenance, PPAP (as applicable), and SCAR/NCR management.
- Evaluate compliance of materials and/or processes with specification and customer requirements
- Collect, analyze, interpret and summarize statistical data
- Perform defect analysis on components and finished goods
- Create validation protocols, summaries, and approvals
- Initiate corrective action requests on discrepant product/processes and verify adequacy and accuracy of corrective action taken internally and/or externally
- Assist in Design of Experiments to improve process/product
- Assist other functions in the timely disposition of material to support operational objectives
- Perform analyses and provide reports to management
- Bachelor's Degree in Chemistry, Biochemistry or Biochemical Engineering & 2 years of experience in Quality or Engineering or a relevant Masters degree
- Project management experience (familiarity with Microsoft Project - Gantt Charts).
- Familiarity with Lab operations/management. Process Validation and/or Root Cause Analysis experience.
- Working knowledge of statistical methods and applications (Minitab experience a plus).
- ASQ Certification desired
- Working knowledge of Six Sigma, DFMEA, PFMEA and Risk Management Tools
- Strong communication, manufacturing process, product industrialization and leadership skills
- Solid design, troubleshooting and presentation skills
- Strong project management skills
- Well versed in molding, stamping and machining methods.
- Tooling and processing experience a plus.
- Experience in assembly equipment technologies
- Analyze and chart statistical and process data using Minitab, MS Excel, or equivalent
- Working knowledge of 21CFR820, ISO13485, Canadian MDR and MDD 93/42/EEC Knowledge of validation process protocol creation and summaries
- Proficient in Project Management Familiar with the Product development process
*****This is a W2 contract only, no sponsorship!!*****
Sthree US is acting as an Employment Business in relation to this vacancy.