Quality Engineer: Medical Device Quality & CAPA Leader

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

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