Quality Engineer II

The position is primarily responsible for reviewing and approving risk management documentation, process validation activities, and quality-related project deliverables. Additionally, the Quality Engineer II is the owner of the Measurement System Analysis (MSA) and Incoming Inspection programs, ensuring their effectiveness and compliance with applicable procedures and regulatory requirements. This role also serves as a key quality liaison with customers, maintaining communication on quality-related topics, project status, risk management, validation activities, and issue resolution throughout the NPI lifecycle.

Key Responsibilities

• Review and approve PFMEAs and other risk management documentation generated by project teams.
• Review and approve process validation protocols and reports, including IQ, OQ, and PQ activities.
• Serve as the owner of the Measurement System Analysis (MSA) program, ensuring the adequacy, execution, and maintenance of measurement system studies.
• Manage and maintain the Incoming Inspection program, including inspection plans, acceptance criteria, and ongoing effectiveness monitoring.
• Conduct audits of project activities and quality deliverables to ensure compliance with internal procedures, regulatory requirements, and quality standards.
• Participate in NPI projects, design reviews, and manufacturing transfer activities as the Quality representative.
• Identify quality risks and escalate concerns that may impact product quality, compliance, or project timelines.
• Support internal, customer, and regulatory audits.
• Monitor and report quality metrics related to NPI and Incoming Inspection activities.
• Serve as the primary Quality contact for customers during NPI projects, providing updates and support on quality-related topics, including risk management, validation activities, inspection strategies, nonconformances, and corrective actions.
• Participate in customer meetings and communicate quality requirements, concerns, and project-related quality status to ensure alignment and customer satisfaction.

Preferred Qualifications

• Bachelor's degree in Engineering or a related technical field.
• Minimum of 3 years of experience in Quality Engineering within a regulated manufacturing environment.
• Experience supporting New Product Introduction (NPI), technology transfers, or process implementation projects.
• Strong knowledge of PFMEA, IQ/OQ/PQ validation methodologies, MSA, auditing techniques, and Incoming Inspection processes.
• Familiarity with ISO 13485, FDA Quality System Regulations (QMSR), or equivalent regulatory standards.
• Advanced English communication skills.
• Strong analytical, organizational, and cross-functional collaboration skills.

Key Competencies

• Quality Systems Compliance
• Risk-Based Thinking
• Attention to Detail
• Auditing and Oversight
• Problem Solving and Critical Thinking
• Effective Communication
• Project and Priority Management
• Decision Making Based on Data and Compliance Requirements