Sr. Quality Engineer

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA

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.
• 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. 
• Investigate and collaborate in the investigation of atypical events to support product disposition

Qualifications:

• Bachelor Degree in Engineering (Software, Mechanical and Chemical Engineering preferred)
• Four (4) years of previous experience 
• Experience in design transfer and new product implementations
• Ability to use statistical techniques to analyze data
• Capable of developing/reviewing/approving test plans and reports
• Knowledge of cGMP, PFMEA, PV, Technical Writing
• Experience with CSV and Equipment Qualification
• Experience establishing process development and validation strategies
• Adept interpersonal/influencing skills, especially guiding less experienced resources.
• Knowledgeable of medical devices manufacturing regulations
• Availability for 1st 2nd and 3rd shift