Quality Manufacturing Engineer

The Quality Manufacturing Engineer is responsible for providing quality engineering support across manufacturing operations, product transfer activities, and product lifecycle management to ensure products consistently meet customer, regulatory, and company requirements. This position partners closely with Manufacturing Engineering, Transfer Engineering, Operations, and Quality teams to support design changes, manufacturing improvements, validation activities, and resolution of quality issues within a regulated medical device environment.

The Quality Manufacturing Engineer serves as a technical resource for problem solving, root cause investigations, CAPA activities, design control support, and continuous improvement initiatives while ensuring compliance with FDA regulations, ISO 13485 requirements, and the Aptyx Quality Management System.

Essential Duties and Responsibilities


Quality Systems and Compliance

• Follow the Aptyx Quality Management System, including all applicable Standard Operating Procedures (SOPs) and Work Instructions identified within the Training Matrix.
• Ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, and applicable customer specifications.
• Create, revise, and implement quality procedures, forms, specifications, and work instructions.
• Provide quality engineering support during internal audits, external audits, and regulatory inspections.
• Conduct internal quality system audits, process audits, and supplier audits as assigned.

Manufacturing Quality Support

• Partner with Manufacturing Engineering and Production teams to support daily manufacturing operations and address quality-related production concerns.
• Analyze nonconforming conditions in production to determine root cause using structured problem-solving methodologies.
• Lead and facilitate corrective and preventive actions (CAPA) to eliminate recurring quality issues.
• Monitor quality trends and summarize findings to identify opportunities for improvement.
• Support production improvement initiatives focused on defect reduction, process capability enhancement, and operational efficiency.

Product Transfer and Validation

• Collaborate with Transfer Engineers to support product and process transfer activities between manufacturing locations.
• Support process validations, equipment qualifications, and transfer validation studies.
• Work cross-functionally to ensure manufacturing readiness and quality requirements are met during transfer activities.
• Develop and document control plans defining in-process and final verification requirements.

Design Control and Change Management

• Support Design Control activities in accordance with regulatory requirements, including design verification and validation activities as applicable.
• Participate in Design Change Management processes by evaluating proposed changes for quality impact and ensuring appropriate documentation is completed.
• Provide quality input into risk assessments and implementation of design modifications.

Inspection and Measurement Systems

• Supervise and perform testing and inspection activities as required.
• Train and mentor Quality Inspectors and Quality Technicians on inspection methods and quality requirements.
• Review components, products, and processes to optimize inspection methods, sampling plans, and associated documentation.
• Maintain inspection records and ensure documentation accuracy and completeness.
• Plan and document Measurement System Analysis (MSA) studies, including Gauge Repeatability and Reproducibility (GR&R) assessments.
• Conduct process capability studies and statistical analyses to support process improvements.

Sterilization Support

• Support sterilization programs across Aptyx manufacturing locations.
• Establish and maintain product-specific sterilization requirements.
• Maintain validated standard sterilization cycles and associated documentation.

General Responsibilities

• Provide technical quality support to cross-functional teams as needed.
• Train employees regarding quality standards, procedures, and regulatory expectations.
• Support special projects and initiatives as assigned by management.

Qualifications

• Six Sigma Green Belt preferred.
• ASQ Certified Quality Engineer (CQE) certification preferred.

Education

• Bachelor's degree in Engineering or related technical discipline required.
• Equivalent combination of education and directly related experience may be considered.

Experience

• Minimum of 3-5 years of Quality Engineering experience within the medical device industry required.
• Equivalent experience of 5-8 years supporting quality functions in regulated manufacturing environments may be considered.
• Experience supporting manufacturing operations, product transfers, and design change activities preferred.
• Experience with CAPA, root cause analysis, and nonconformance investigations required.
• Experience with internal auditing and supplier quality activities preferred.
• Working knowledge of FDA Quality System Regulations and ISO 13485 standards required.

Skills, Knowledge, and Abilities

• Thorough understanding of FDA 21 CFR Part 820 and ISO 13485 requirements.
• Knowledge of Design Controls and Design Change Management processes.
• Understanding of validation principles including IQ/OQ/PQ methodologies.
• Strong technical knowledge of medical device manufacturing processes and quality assurance principles.
• Proficiency with statistical analysis techniques including Statistical Process Control (SPC), process capability studies, and Design of Experiments (DOE).
• Experience utilizing structured problem-solving methodologies and root cause analysis tools.
• Ability to interpret engineering drawings, specifications, and regulatory requirements.
• Proficient in Microsoft Office applications and quality-related software systems.
• Strong analytical, organizational, and project management skills.
• Excellent written and verbal communication skills.