American Surgical Company is seeking an experienced and results-driven Quality Engineer to join our Quality team. This hands-on role is responsible for developing, implementing, and sustaining quality systems and processes that ensure products and manufacturing operations comply with internal quality standards and external regulatory requirements, including ISO 13485 and FDA Quality System Regulations. The Quality Engineer will lead quality improvement initiatives, support risk management activities, drive investigations and corrective actions, and partner closely with Manufacturing, R&D, Regulatory Affairs, and Operations teams to ensure product quality, patient safety, and regulatory compliance.
The ideal candidate will possess strong analytical and problem-solving skills, experience working in a regulated manufacturing environment, and a proven track record of driving continuous improvement through data-driven quality engineering practices.
Essential Duties and Responsibilities:
- Develop, implement, and maintain quality assurance and quality control processes, procedures, work instructions, and other controlled documentation in compliance with ISO 13485, FDA regulations, and internal quality system requirements.
- Lead investigations into nonconformances, customer complaints, supplier quality issues, and manufacturing defects using structured root cause analysis methodologies.
- Drive corrective and preventive actions (CAPA) to closure, ensuring effectiveness checks are completed and sustainable solutions are implemented.
- Analyze quality data, including defect trends, process capability studies, yield metrics, complaint data, and audit findings to identify opportunities for continuous improvement.
- Lead and support risk management activities, including DFMEA, PFMEA, hazard analysis, and risk mitigation strategies throughout the product lifecycle.
- Support validation activities, including IQ/OQ/PQ, test method validations, and process validation studies to ensure compliance with regulatory and quality requirements.
- Partner with Manufacturing Engineering and Production teams to improve process capability, reduce variability, and enhance product quality and operational efficiency.
- Support new product introduction (NPI) and design transfer activities by ensuring quality requirements are incorporated into manufacturing processes and documentation.
- Review engineering drawings, specifications, design documentation, and manufacturing processes to ensure compliance with applicable standards and customer requirements.
- Develop and maintain inspection methods, sampling plans, test protocols, and measurement systems to support product acceptance and process monitoring.
- Perform statistical analyses using quality tools and software to support process improvement, validation, and decision-making activities.
- Support internal, supplier, customer, and regulatory audits, including preparation, participation, response development, and follow-up actions.
- Collaborate with suppliers to resolve quality issues, conduct supplier evaluations, and support supplier qualification activities.
- Lead or participate in change control activities, including evaluation of quality impacts associated with engineering changes, process changes, and material changes.
- Monitor and report key quality metrics, including nonconformances, CAPA effectiveness, complaint trends, audit findings, and process performance indicators.
- Prepare technical reports, presentations, and quality documentation to communicate findings, recommendations, and project status to stakeholders.
- Provide training and guidance to personnel on quality system requirements, quality tools, and best practices.
Skills:
- Strong analytical and problem-solving abilities with a data-driven approach.
- Strong understanding of quality engineering principles and methodologies, including: o CAPA (Corrective and Preventive Actions)
o FMEA (Failure Mode and Effects Analysis)
o SPC (Statistical Process Control)
o MSA (Measurement System Analysis)
o Root Cause Analysis
o Risk Management (ISO 14971)
- Experience with process validation, test method validation, and equipment qualification activities.
- Familiarity with ISO 13485, FDA Quality System Regulations (21 CFR Part 820/QMSR), and other applicable regulatory requirements.
- Experience with UDI/GUDID compliance and labeling change control activities is a plus.
- Familiarity with product technical files and manufacturing/batch records in a regulated environment is a plus.
- Proficiency with statistical analysis tools such as Minitab.
- Strong technical writing skills with the ability to develop and maintain compliant quality documentation.
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
- Strong organizational and project management skills with the ability to manage multiple priorities.
- Effective communication and collaboration skills across cross-functional teams.
- Ability to work independently while providing leadership on quality initiatives.
- Comfortable working in a manufacturing environment, including Class 8 Cleanroom operations.
- Detail-oriented with a commitment to product quality, compliance, and continuous improvement.
Education and Experience:
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Quality Engineering, Industrial Engineering, Materials Engineering, or a related technical discipline.
- 3–7 years of experience in a manufacturing or regulated operations environment, preferably within the medical device industry.
- Experience supporting quality systems compliant with ISO 13485 and FDA regulations.
- Hands-on experience with CAPA, nonconformance investigations, root cause analysis, and quality improvement initiatives.
- Experience with risk management activities, including FMEA and risk assessments.
- Experience supporting process validations (IQ/OQ/PQ), test method validations, and change control processes.
- Experience supporting new product introductions, design transfer activities, or product lifecycle management is strongly preferred.
- Knowledge of Lean Manufacturing and Six Sigma methodologies; certification is a plus.
- Experience participating in internal, supplier, customer, or regulatory audits is preferred.
- ASQ Certified Quality Engineer (CQE) certification is a plus.
Language Skills:
- Must be fluent in English, with the ability to read, write, and communicate technical information clearly and effectively in both verbal and written formats.
Proficiency in Spanish is a plus and may be beneficial for effective communication in a diverse manufacturing environment.
Compensation & Benefits
American Surgical Company offers a competitive compensation and benefits package, including eligibility to participate in the Company's Profit Sharing Program in accordance with plan provisions and eligibility requirements.
Schedule: Monday-Friday (8:00 AM - 4:30 PM)
This role is not eligible for visa sponsorship at this time.
Pay: $110,000.00 - $130,000.00 per year
Work Location: In person
