Job Information
Quality Consulting Group JT610 - QUALITY ENGINEER I in Ponce, Puerto Rico
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.
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.
Qualifications:
Bachelor's degree in engineering
3 years of related experience
Resource with vast expertise in Product transfer and Validation Area, reviewing validation documents (CSV, IQ, OQ, PQ and Software Validation)
Validation and Product Transfer Knowledge
Also vas experience and expertise in test method Validation (MSA).
Statistical Knowledge and experience performing Attribute Agreement Analysis, DOE, Gage R&R, Ppk analysis, normality tests, tolerance interval for normal and non-normal data.
Experience generating Process maps, process flows and standard operating procedure changes.
Statistical Analysis Knowledge
Compliance and Technical writing knowledge
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.
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