JT672 - QUALITY ENGINEER II

Quality Consulting Group • Juncos, PR

6d

About The Position

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.

Requirements

• Bachelor's degree in engineering (Mechanical, Electrical or Chemical preferred)
• 4+ years of relevant experience
• Experience with Risk management documentation: pFMEAs
• Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory)
• Basic knowledge in statistics (preferably using Minitab)
• Basic knowledge in defining validation strategies (e.g. requirements flow down from design to manufacturing)
• Experience investigating manufacturing operations events in support to product disposition
• Experience assessing and tracing manufacturing defects/rejects trends
• Knowledge in Medical Devices regulations
• Experience working and executing Design transfer activities
• Experience with projects to implement new products: design requirements validation, manufacturing controls (not Operational Excellence)
• Experience reviewing and approving validation test plans, reports, and deviations
• Capable of performing statistical analysis to support validations and product release
• Available for 1st shift

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.
• Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees