Prefer experience in Med. Device, but will consider other types of manufacturing (preferably aerospace or pharmaceutical).
Perform Quality Assurance/Quality Engineering under broad direction to ensure components, finished products and processes meet established specifications. Analyze material and processes and make recommendations/ take action to correct deficiencies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Evaluate compliance of materials and/or processes with specification and customer requirements
2. Collect, analyze, interpret and summarize statistical data
3. Perform defect analysis on components and finished goods
4. Create validation protocols, summaries, and approvals
5. Initiate corrective action requests on discrepant product/processes and verify adequacy and accuracy of corrective action taken internally and/or externally
6. Assist in Design Of Experiments to improve process/product
7. Assist other functions in the timely disposition of material to support operational objectives
8. Perform analyses and provide reports to management
Department Specific/Non-Essential Functions:
1. Assist suppliers in developing inspection methods
2. Perform Gage R&R and correlation studies
3. Work with QA Technicians to resolve measurement and testing issues
4. Work with QA departments to resolve blueprint/specification issues
5. Work with other departments to resolve issues related to material and process quality, including FMEA, DOE, SPC
6. Develop Control Plans, Inspection Instructions and other documents as needed to effectively manage product/process quality
7. Develop and review documented operating procedures associated with material inspection or processes
8. Work directly with suppliers to prevent or correct discrepant material
9. Compile and issue monthly reports to management
10. Assign primary responsibilities and tasks to QA department
11. Other duties as assigned with or without accommodation
12. Support CAPA activities
• 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
• Working Knowledge of Six Sigma
• Working knowledge of GD&T
• Working knowledge of DFMEA, PFMEA, and Risk Tools
• Working knowledge of DFA/ DFM principles
• 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
• Product development process
Excellent verbal and presentation skills including technical writing.
Strong Organizational and Project Management skills
MS Office Suite, Minitab
Bachelor’s Degree in Engineering (or related field).
ASQ certification or equivalent is desirable.
Minimum 2 years of related work experience in Manufacturing or Quality Engineering, or equivalent.
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