"Alerted.org

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.

+ 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.

Qualifications:

+ Bachelor's degree in engineering (Mechanical, Elecal 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

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Powered by JazzHR