JT375 - QUALITY ENGINEER I

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: 

• Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
• The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.
• 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.

Qualifications:

• Bachelor's degree in engineering (Software, Mech and Chem Engineering preferred)
• 4 years of relevant experience 
• Experience reviewing and approving validation test plans, reports, and deviations
• capable of performing statistical analysis to support validations and product release
• knowledgeable of medical devices manufacturing regulations
• Ability to use statistical techniques to analyze data
• collaborative attitude
• Experience in CSV
• Experience in medical device industry
• Experience in Process Validation and Equipment qualification
• Experience in risk management documents (e.g. pFMEA)
• Experience in manufacturing events investigations
• Available for 1st, 2nd or 3rd shift