Quality Engineer

The Quality Engineer is responsible for providing quality engineering support to manufacturing operations and quality systems to ensure products are manufactured in compliance with applicable regulatory requirements, quality standards, and company procedures. The Quality Engineer serves as a technical resource for process improvement, investigations, validations, risk assessments, and quality system activities while supporting the manufacture of safe and effective products that meet customer and regulatory requirements.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
·       Provide quality engineering support for manufacturing processes to ensure compliance with FDA regulations, ISO standards, GMP requirements, and company quality system procedures.
·       Lead and support investigations related to nonconformances, deviations, customer complaints, out-of-specification results, audit findings, and other quality events to determine root cause and implement effective corrective and preventive actions (CAPA).
·       Evaluate manufacturing processes and quality data to identify trends, improve process capability, reduce defects, and drive continuous improvement initiatives.
·       Develop, review, and approve quality documentation, including procedures, work instructions, specifications, protocols, reports, risk assessments, and validation documentation.
·       Support product and process validation activities, including IQ/OQ/PQ, process validation, cleaning validation, software validation, and test method validation, as applicable.
·       Participate in change control activities by assessing the quality and regulatory impact of proposed changes to products, processes, materials, equipment, and systems.
·       Utilize quality engineering tools and methodologies, including statistical analysis, process capability studies, root cause analysis, Failure Mode and Effects Analysis (FMEA), and risk management techniques.
·       Analyze quality metrics and performance indicators, including scrap, yield, nonconformances, complaint trends, and process performance data, and recommend improvement actions.
·       Collaborate with Manufacturing, Engineering, Operations, Regulatory Affairs, Supply Chain, R&D, and Validation teams to ensure quality requirements are incorporated into products and processes.
·       Support internal audits, supplier audits, customer audits, and regulatory inspections, including the development and implementation of corrective actions resulting from audit observations.
·       Develop, improve, and validate inspection and test methods to ensure reliable and accurate evaluation of product quality.
·       Ensure that risk management principles are incorporated into quality and manufacturing processes throughout the product lifecycle.
·       Monitor customer feedback, complaints, and post-market quality data to identify opportunities for product and process improvements.
·       Provide technical guidance and quality training to manufacturing personnel and quality staff regarding quality requirements, procedures, and best practices.
·       Support regulatory submissions, FDA inspections, notified body audits, and other regulatory activities as required.
·       Promote a culture of quality, compliance, continuous improvement, and patient/customer focus throughout the organization.
·       Ensure compliance with all applicable safety, environmental, and company policies.
·       Perform other duties and projects as assigned.

Education and Experience:
Education:
·       Bachelor’s degree in Engineering
·       Master’s degree in Engineering Preferred.
Experience:
·       Minimum of four (4) years of experience in Engineering or Quality Engineering within the medical device, pharmaceutical, or equivalent industry if holding a Bachelor’s degree
·       Minimum of two (2) years of experience in Engineering or Quality Engineering within the medical device, pharmaceutical, or equivalent regulated industry if holding a Master’s degree.

Knowledge and Skills:
·       Knowledge of FDA Quality System Regulation (21 CFR Part 820) and/or Pharmaceutical GMP requirements (21 CFR Parts 210/211).
·       Knowledge of ISO 13485 and risk management principles (ISO 14971) for medical devices.
·       Root Cause Analysis, CAPA, and Investigation Management.
·       Process Validation and Test Method Validation.
·       Statistical Analysis and Process Capability.
·       Change Control and Risk Assessment.
·       Audit Readiness and Regulatory Compliance.
·       Continuous Improvement and Lean Manufacturing principles.
·       Strong technical writing and documentation skills.
·       Cross-functional collaboration and project management.
·       Certification as a Quality Engineer (CQE), ASQ certification, or equivalent is a plus.
·       Ability to communicate effectively in English, both verbally and in writing, required.
·       Bilingual (English/Spanish) preferred.