Quality Engineer II

Key Responsibilities

• Serve as the Quality representative on product development and process change project teams.
• Ensure Design Control requirements are appropriately applied to new product development and product or process changes.
• Support design transfer and product lifecycle activities through collaboration with cross-functional teams.
• Create, review, and maintain documentation required for Design History Files (DHF).
• Create and review Quality System documentation, including procedures, work instructions, and records.
• Develop and review product documentation to support regulatory and quality requirements.
• Generate and support quality documentation, including Requests for Service (RFS), Engineering Change Requests (ECR), Product Quality Reports (PQR), and related quality records.
• Ensure compliance with corporate, divisional, and departmental procedures.
• Create and review validation documentation including: Process Validation Protocols, Product Validation Protocols, Stability Protocols, Test Methods, Validation Reports.
• Support equipment, process, software, and product validation activities.
• Develop and review risk assessments, including: Failure Mode and Effects Analysis (FMEA), Failure Mode, Effects and Criticality Analysis (FMECA), Fault Tree Analysis (FTA).
• Audit & Compliance Support: Participate in internal and supplier quality audits. Support Quality Management System compliance activities. Assist in maintaining compliance with FDA regulations and applicable quality standards. Assist in continuous improvement initiatives related to quality and compliance.
• Collaboration & Professional Development: Collaborate with manufacturing facilities and other divisional locations to support quality objectives. Provide guidance and support to project teams and quality initiatives as needed. Participate in professional organizations and industry activities to remain current on regulatory requirements and industry best practices. Travel as required to support project, audit, and quality activities.

Required Qualifications

• Education: Bachelor's degree in Engineering, Engineering Technology, Science, or a related technical discipline.
• Experience: Minimum of 3 years of experience in an FDA-regulated industry. Experience working within Quality Systems, Quality Assurance, Quality Engineering, Manufacturing Quality, or related functions.
• Knowledge: Working knowledge of Quality Management Systems and regulatory requirements. Understanding of Design Controls and risk management principles. Experience writing and executing process, software, equipment, or product validation protocols. Knowledge of manufacturing processes and quality engineering principles. Familiarity with basic applied statistics and data analysis methods. Ability to translate quality and regulatory requirements into product and process specifications. Strong technical writing, documentation, and organizational skills. Excellent verbal, written, and presentation skills. Ability to effectively prioritize workload and manage multiple assignments. Strong problem-solving and analytical skills. Ability to work independently and effectively within cross-functional teams.
• Preferred Qualifications: Minimum of 2 years of experience supporting product development programs. Experience supporting Design Controls, quality systems, validation activities, or product quality engineering functions. Experience supporting Design History Files (DHF), Engineering Change Requests (ECR), or product change activities. Experience conducting internal or supplier audits. Medical device industry experience.

Work Environment

• Combination of office and manufacturing environments.
• Occasional travel, including visits to manufacturing facilities, suppliers, clinical sites, or hospitals. (15%)
• May occasionally lift up to 25 pounds.