Quality Engineer (NY)

Aspen Surgical; Hempfield Township (Westmoreland County); On-site; USD 70,000 - 90,000; Full time

Job summary

Aspen Surgical is seeking a Quality Engineer to support a chemical mixing and medical device manufacturing operation. You will ensure compliance with FDA QSR, ISO 13485, and other regulatory requirements while leading complaints handling, CAPA, change control, and supplier quality programs on the shop floor.

In this role you will collaborate with Manufacturing, Engineering, Supply Chain, and Regulatory Affairs to improve product quality, process robustness, and continuous improvement across the

Qualifications

• Bachelor’s degree in engineering or related technical discipline.
• 3–5 years of quality engineering in a regulated medical device/pharma environment.
• ASQ CQE or CQA certification is a plus.
• Experience with FDA QSR/ISO 13485 and medical devices.
• Strong problem solving and cross-functional collaboration.

Responsibilities

• Provide day-to-day quality support for operations.
• Review batch records, deviations, and nonconforming material investigations.
• Develop test methods for inspecting and evaluating product and processes.
• Lead complaint investigations and CAPA activities.
• Participate in change control and supplier quality programs.
• Ensure compliance with FDA QMSR, ISO 13485, and EU MDR.
• Support internal, supplier, and regulatory audits.

Skills

CAPA

FDA QMSR

ISO 13485

Root cause analysis

Change control

Supplier quality

Education

Bachelor’s Degree in Engineering or related technical discipline

ASQ CQE / CQA (nice to have)

Tools

MS Office

Job description

Summary

The Quality Engineer supports a chemical mixing / medical device manufacturing operation, ensuring compliance with applicable quality system regulations while providing direct shop-floor quality support. This role is responsible for complaints management, CAPA, change control, and supplier quality management, and works cross-functionally with Manufacturing, Engineering, Supply Chain, and Regulatory Affairs to drive product quality, process robustness, and continuous improvement.

In This Position, You Will Have The Opportunity To

Shop Floor Quality

• Provide day-to-day quality support for operations
• Perform batch record review, deviations, nonconforming material investigations, and process troubleshooting
• Develop and implement test methods and procedures for inspecting, testing and evaluating product and processes

Complaints & Post-Market Surveillance

• Lead and/or participate in complaint investigations in accordance with FDA QSR, ISO 13485, and customer requirements
• Perform root cause analysis and ensure appropriate corrective and preventive actions
• Conduct trend analysis, escalation, and regulatory reporting (e.g., MDR support as applicable)
• Interface with customers regarding complaint investigations and responses when required

Corrective and Preventive Action (CAPA)

• Own and manage CAPA records, from initiation through effectiveness verification
• Apply structured problem‑solving tools (e.g., 5‑Why, Fishbone, FMEA)
• Monitor CAPA metrics, timeliness, and effectiveness to ensure sustained improvement
• Address CAPAs identified during internal and external audits

Change Control

• Participate in change control activities related to materials, suppliers, processes, equipment, and documentation
• Assess quality and regulatory impact of proposed changes, including risk evaluations
• Ensure changes are implemented in compliance with customer requirements and applicable regulations
• Assist with validation and verification activities as required

Supplier Quality Management

• Execute Supplier Quality initiatives and programs with activities such as supplier qualification, auditing, SCAR management, and PPAP
• Perform supplier qualification, monitoring, and performance management
• Review and approve supplier documentation (COAs, specifications, quality agreements)
• Participate in supplier audits, issue supplier corrective actions, and track resolution
• Maintain incoming inspection strategies and supplier risk assessments

Quality System & Compliance

• Ensure compliance with applicable regulations (FDA’s QMSR, ISO 13485, EUMDR, ISO 14971)
• Participate in internal, customer, and regulatory audits, including preparation and response activities
• Perform data analysis and reporting of quality metrics (scrap, rework, complaints, CAPA)

What You Need To Succeed In This Position

• Bachelor’s Degree in Engineering preferred, or a related technical discipline such as Chemistry or Biology.
• A minimum of 3–5 years of quality engineering experience in a medical device, pharmaceutical, or regulated manufacturing environment.
• ASQ certification a plus (CQE, CQA)
• Experience in chemical mixing, liquid formulation, or filling operations preferred.
• Displays developed interpersonal skills: leadership, team orientation, ability to communicate at all levels.
• Ability to make effective decisions and maintain effectiveness under changing circumstances and priorities.
• Teamwork, communication, positive attitude required to support the manufacturing environment.
• Problem Solving – able to perform root cause analysis and implement effective corrective actions.
• Able to effectively manage and complete multiple projects simultaneously.
• Excellent computer skills including but not limited to Microsoft Office Suite.
• Knowledge of quality systems including the quality manual, quality policy and applicable procedures and work instructions.
• Ability to support the establishment, implementation, and maintenance of the quality system in accordance to FDA Quality Management System Regulation, ISO 13485, and European Union Medical Device Directives.

We’re proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status.