Quality Engineer

Our client has an immediate need for a Quality Engineer to support new product development, validation, and ongoing quality improvement initiatives. In this role, you will partner closely with the Engineering and Operations teams to ensure products and processes meet customer, regulatory, and quality requirements from concept through commercialization.

You will support validation projects through statistical evaluations, interface with customers to align on expectations, and work with the QC inspection team and Metrologist to establish proper inspection techniques. On a limited basis, you will also support sustaining quality initiatives including nonconformance investigations, corrective actions, and continuous improvement activities.

Essential Functions & Responsibilities

New Product Introduction (NPI) & Risk Management

• Lifecycle Support: Drive quality activities throughout the NPI lifecycle, from design transfer through production launch.
• Cross-Functional Collaboration: Participate in project teams to ensure quality requirements are incorporated into product and process development.
• Risk Assessment: Support risk management activities, including PFMEA and formal risk assessments.
• Documentation Review: Review engineering changes, specifications, drawings, and manufacturing documentation for quality impact.

Validation & Statistical Analysis

• Validation Execution: Support validation development, execution, and documentation (IQ/OQ/PQ protocols/reports, process validations, equipment qualifications, and test method validations).
• Statistical Methods: Utilize Minitab and statistical tools to analyze and communicate process capability, performance, and key Statistical Process Control (SPC) data.
• Data Inspection: Analyze process and product data to identify trends, risks, and optimization opportunities.
• Inspection Standards: Develop inspection methods, sampling plans, and acceptance criteria per industry standards and customer specifications.

Quality Assurance & Compliance

• Issue Resolution: Collaborate with suppliers and internal stakeholders (Operations, Tooling, Engineering, Quality) to resolve quality issues.
• Root Cause Analysis: Investigate nonconformances and customer complaints using structured problem-solving to determine root cause and implement CAPA.
• Regulatory Compliance: Ensure alignment with quality standards and regulatory requirements, including ISO 13485 and FDA QSR.
• Audit Readiness: Assist with internal and external audits, maintaining overall audit readiness.
• Metrics & Training: Develop quality metrics for validation and NPI, and provide quality guidance/training to manufacturing, engineering, and QC personnel.

Technical Skills

• Strong understanding of validation principles (IQ/OQ/PQ methodologies) and statistical techniques.
• Proficiency in Minitab, Microsoft Office, and electronic ERP/QMS platforms.
• Ability to read, analyze, and interpret complex technical documents and engineering drawings.
• Standards Knowledge: Hands-on knowledge of ISO 9001, ISO 13485, and FDA QSR requirements.
• Communication: Ability to effectively communicate (verbal and written) with internal personnel, customers, and suppliers.
• Preferred Certifications: ASQ Certified Quality Engineer (CQE) and/or Lead Auditor Training is a strong plus.

Qualifications & Requirements

• Education: Bachelor’s Degree in Engineering, Technical discipline, or equivalent experience preferred.
• Experience: 5 years of experience in validation, risk management, and quality systems within a regulated manufacturing environment.