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