Senior Quality Engineer - GMP & Validation Expert

Quality Consulting Group, LLC; Humacao (PR); Vor Ort; USD 70.000 - 110.000; Vollzeit

Zusammenfassung

QUALITY CONSULTING GROUP, LLC seeks a quality-focused engineer to develop and maintain quality standards in FDA/ISO environments across Puerto Rico and the USA.

You will collaborate with engineering and manufacturing, design QA tests, and perform statistical analysis to ensure compliance and continuous improvement in a world-class manufacturing setting.

Qualifikationen

• Bachelor’s or Master’s degree in Mechanical, Industrial, or Electrical Engineering, or a related field.
• Experience in FDA/ISO-regulated manufacturing environments, including GMP compliance.
• Knowledge of validation (IQ/OQ/PQ) and manufacturing processes with risk-based validation.
• Proficiency in problem-solving, risk assessment and data analysis tools (FMEA, 5 Whys, SPC, DOE) and trend analysis.
• Lean Six Sigma certification and automation/programming experience preferred.
• Strong communication, collaboration, continuous improvement and critical-thinking skills.
• Availability for 1st shift and 2nd shift.

Aufgaben

• Develops, modifies, applies and maintains quality standards and protocols for processing materials.
• Collaborates with engineering and manufacturing functions to ensure quality standards.
• Designs inspection and testing mechanisms; conducts QA tests; performs statistical analysis.
• Ensures corrective measures meet reliability standards and documentation compliance.
• Specialize in design, incoming material, production control, product evaluation, or R&D as applied.
• Oversees equipment and process validation activities.
• Supports regulatory compliance and change management initiatives.

Kenntnisse

Problem solving

Risk assessment

Data analysis

Lean Six Sigma

Automation/programming

Communication

Collaboration

Continuous improvement

Critical thinking

Ausbildung

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

Tools

Minitab

JMP

Excel

Power BI

SAP

Jobbeschreibung

QUALITY CONSULTING GROUP, a leader inthe 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.
• Equipment & Process Validation
• Quality Systems & Change Control
• Regulatory Compliance & Manufacturing Change Management

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 businesssystems (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 and 2shift

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.