Quality Engineer (Medical Devices)

Location: On-site in Norristown, Pennsylvania, United States; up to 15% travel required.

Salary: $79,000–$119,000 annual, plus bonus and/or incentive eligibility.

Company

hirify.global is a growing worldwide medical products organization offering quality, engineering, and regulatory-focused career opportunities.

What you will do

• Develop and implement methods for process control, validation, improvement, testing, and inspection.
• Design experiments and analyze process data using statistical process control, probability, and statistical quality control methods.
• Conduct product testing, analyze defects and trends, and lead corrective actions.
• Manage supplier quality issues, qualifications, CAPA, and SCAR implementation.
• Support product development, design control, risk management, CE Technical Files, Device Master Records, and 510(k) submissions.
• Investigate non-conformances and out-of-specification results while ensuring compliance with applicable regulations.

Requirements

• Bachelor’s degree in Engineering, Science, Math, or a related technical field.
• At least 2 years of experience in Quality or Engineering.
• Working knowledge of quality assurance codes and standards, including 21 CFR 820 and ISO 13485.
• Intermediate Microsoft Excel skills, including conditional formatting, tables, formulas, and charting, plus proficiency with Microsoft Office.
• Strong problem-solving, organization, time-management, and independent working skills.
• Ability to work on-site in Norristown, Pennsylvania, with up to 15% travel.

Nice to have

• At least 2 years of industry experience in medical devices, drugs, or a directly related field.

Culture & Benefits

• Health insurance, life and disability insurance, 401(k) contributions, and paid time off for eligible employees.
• Continuing education and training opportunities.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access where applicable.
• Inclusive workplace focused on belonging, diversity, and career growth.