How will you make an impact?

As a Quality Engineer, you will support key quality systems, ensure compliance with internal and regulatory standards, and provide day-to-day engineering support to manufacturing operations. Your work will drive continuous improvement, enhance customer satisfaction, and contribute directly to product and process excellence.

What will you do?

• Promote and uphold site safety policies and procedures.
• Support key business metrics by providing Quality Engineering expertise for manufacturing processes.
• Conduct root cause analyses for quality issues using tools such as 8D, A3, and Six Sigma.
• Perform statistical analyses including ANOVA, DOE, Weibull, GR&R, capability studies, FMEA, and TMV.
• Evaluate, design, and implement inspection and process control systems.
• Assist in validation activities for processes, equipment, software, and computerized systems.
• Prepare and maintain clear documentation including protocols, reports, and procedures.
• Support new product introductions and process transfers.
• Participate in complaint investigations, nonconformances, and CAPA activities.
• Collaborate cross-functionally in quality review meetings (e.g., CAC, TIC, MIC, QIC).
• Engage in internal/external audits and regulatory compliance activities.
• Provide training and guidance to manufacturing personnel on quality standards and inspection techniques.
• Lead or support continuous improvement and cost-reduction initiatives.

How will you get here?

Education:

• Bachelor’s degree required; Engineering or related technical field preferred.

Experience:

• Minimum of 2 years of relevant experience in Quality Engineering or a regulated manufacturing environment.
• Experience in root cause analysis, process validation, and quality systems.

Knowledge, Skills, Abilities:

• Strong understanding of quality system regulations and standards.
• Proficient in statistical analysis tools and techniques.
• Excellent written and verbal communication skills.
• Strong decision-making, organizational, and problem-solving abilities.
• Ability to work independently and collaboratively across teams.
• Skilled in using PC-based systems including Microsoft Office and quality management software.

Preferred Qualifications:

• Experience with inspection planning, control plans, and validation in a regulated environment.
• Familiarity with Six Sigma or other structured problem-solving methodologies.
• Prior experience participating in audits or regulatory inspections.
• Working knowledge of complaints handling, document control systems, and inventory management tools.
• Certification in Quality Engineering (e.g., CQE) is a plus.

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