Quality Engineer

About the role

The Quality Engineer provides day-to-day quality engineering support for assigned manufacturing operations and product lines. This role is responsible for ensuring products and manufacturing processes meet approved specifications, internal quality requirements, and applicable regulatory standards.

Responsibilities

• Lead or participate in cross-functional product and process improvement teams.
• Lead root cause investigations, develop corrective actions, and drive continuous product improvements across the product lifecycle.
• Ensure internal adherence to established SOPs and document control practices.
• Identify, escalate and investigate product quality and compliance issues using a risk-based approach.
• Establish, maintain, and monitor manufacturing quality metrics for assigned product lines, including first-pass yield, defects, nonconformances, scrap, rework, warranty, RMA, and CAPA.
• Conduct, manage or participate in internal and external audits.
• Develop and maintain inspection plans, control plans, sampling plans, test methods, and acceptance criteria.
• Conduct or support measurement system analysis, including Gage Repeatability and Reproducibility studies.
• Support maintenance of product risk management files based on regulatory (e.g. ISO 14971, MDR, TPED, and PED, etc.) and post-market requirements.
• Support process validation, equipment qualification, revalidation, and manufacturing process changes.
• Review proposed product, process, equipment, material, supplier, and inspection-method changes for quality and validation impact.
• Support supplier quality activities when supplier performance affects manufacturing operations or finished product quality.
• Provide quality-related training and technical guidance to production employees, inspectors, technicians, and cross-functional team members.

Requirements

Master’s in Engineering (or other technical field); OR Bachelor’s in Engineering (or other technical field) plus two years of experience in a regulated environment; OR 10+ years of relevant experience in an associated field.

Ability to read and interpret engineering drawings, specifications, tolerances, work instructions, and inspection requirements.

Proficient in Microsoft Office applications (Excel, Word, and PowerPoint).

Qualifications

• Five or more years of experience in a regulated manufacturing environment, with at least three years in quality engineering, manufacturing quality, or a related quality function.
• Experience with ISO 13485, FDA Quality Management System requirements, and ISO 14971 risk-management principles.
• Familiarity managing and using quality tools such as sampling plans, CAPAs, control charts and root cause analysis methods.
• Experience with Plastic components and PCBA is a plus.
• Strong working knowledge of statistical analysis, six sigma techniques Green Belt or better a plus.
• Previous experience with manufacturing or product quality related data analytics such as process capabilities, SPC, pareto, or other related data analysis methods and systems.
• Minitab and Tableau knowledge is a plus.