JT370 - QUALITY ENGINEER II
Most applications go out cold — see where you stand first. No sign-up to start.
Don't just apply. Show up ready.
Olive works from this exact posting — no sign-up to start.
At a glance
Requirements
Credentials this posting asks for.
Job overview
Quality Consulting Group is hiring a JT370 - QUALITY ENGINEER II. Quality Consulting Group, a leader in pharmaceutical, biotech, medical devices, and manufacturing, seeks a motivated Quality Engineer II to develop and maintain quality standards, collaborate with engineering and manufacturing, and ensure compliance with FDA/ISO regulations in Puerto Rico and the USA.
Key focus areas include Develop, modify, apply and maintain quality standards and protocols for processing materials, Collaborate with engineering and manufacturing functions to ensure quality standards are in place, and Devise and implement methods and procedures for inspecting, testing and evaluating product precision and accuracy.
Important skills include Minitab, JMP, Excel, Power BI, SAP, and FMEA.
Skills & qualifications
Skills
Qualifications
Full job description
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.
-
Collaborate closely with cross-functional teams to develop innovative solutions and improve manufacturing processes.
Qualifications:
-
Bachelor’s or Master’s degree in Mechanical, Industrial, Electrical Engineering, or related field preferred.
-
2+ years of related experience
-
Experience in FDA/ISO-regulated manufacturing environments, including GMP compliance, inspection readiness, ISO 13485, CAPA, nonconformance management, change control, document control, and risk management.
-
Knowledge of validation and manufacturing processes, including equipment, process, product, and software validation (IQ/OQ/PQ), risk-based validation, and manufacturing controls.
-
Proficiency in problem-solving, risk assessment, and data analysis tools, including FMEA, 5 Whys, Fishbone, SPC, DOE, capability analysis, trending, and process monitoring.
-
Experience with quality and business systems (e.g., Minitab, JMP, Excel, Power BI, SAP) and strong communication, collaboration, continuous improvement, and critical-thinking skills; Lean Six Sigma certification and automation/programming experience are preferred.
-
Availability 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
You've read the whole posting — now see how you match it.