Quality Engineer II

Job Description

Job Description

ECHO Consulting Group is a leader in providing solutions for the pharmaceutical, biotechnology, medical devices, and food industries. ECHO Consulting Group delivers high-quality solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management. We are committed to offering exciting career opportunities in a workplace that values trust, respect, teamwork, creative talent, enthusiasm, and diligence. We are looking for talented professionals who are passionate about quality, collaboration, and delivering results. We believe great talent deserves great rewards. That’s why we offer a competitive compensation package and professional development.

Summary of Role:

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals.

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.

Shift : 1st Shift, 2nd Shift

Location : Humacao, PR

Education : Bachelor’s degree in Engineering.

Preferred Qualifications:

• Bachelor’s or Master’s degree in Mechanical, Industrial, Electrical Engineering, or related field preferred.

• 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.

Skills:

• Established and productive individual contributor.

• Works independently with general supervision on larger, moderately complex projects / assignments.

• Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones .

• Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .

• Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

ECHO Consulting Group, Inc. is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.

We assure you that your opportunity for employment with ECHO Consulting Group, Inc. depends solely on your qualifications.