Quality Engineer

Quality Engineer Job in Rochester, NY

Responsibilities:

• Provide necessary definition, development and deployment of the company product quality assurance strategy, addressing all phases of product development, utilizing APQP (Advance Product Quality Planning) principles, including IQ/OQ/PQ validation process.
• Develops and implements risk management tools such as pFMEA, to incorporate into control planning strategies.
• Manages the planning and execution of quality assurance strategies as well as product testing efforts, including all associated resources to meet committed delivery dates, in support of new product launch
• Implements control plan elements to maintain product consistency through all phases of manufacturing, develops and implements standards and methods for inspection, testing and evaluation of materials, products and processes. Will also compile and write manufacturing and inspection instructions/protocols to support this activity
• May direct quality department employees on processes for measuring, testing and tabulating data
• Problem solving using formal CAPA tools

Qualifications:

• Minimum of a four year Engineering / Technical Degree or equivalent experience (i.e. 2 to 4 years)
• ASQ certification, preferred
• Completion of Paulson Training, QMS and cGMP practices are required
• Experience in Plastic Injection Molding, with in medical or pharma manufacturing experience preferred
• Proficient in Geometric Dimensioning & Tolerancing GD&T ASME Y14.5, and specification reading
• Proficient in Design of Experiments (DOE)
• Proficient in process failure modes and effects analysis (pFMEA)
• Strong knowledge of and practical experience using problem solving & root cause analysis tools (e.g. 8D, 5Why, fishbone, cause and effect, etc.