Sr. Quality Engineer (Medtech)

TL;DR

Sr. Quality Engineer (Quality Operations): Overseeing and improving the quality of manufacturing processes for medical devices with an accent on regulatory compliance, validation, and continuous improvement. Focus on implementing CAPAs, conducting root cause analysis, and ensuring adherence to FDA and ISO standards.

Location: Hybrid (Wayne, NJ, US) - 1-2 days at home, site-based.

Salary: $115,000 – $120,000 plus 10% annual bonus

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Develop and maintain quality control processes for manufacturing to ensure compliance with regulatory requirements and industry standards.
• Establish and monitor KPIs to assess manufacturing quality and identify opportunities for improvement.
• Lead validation and verification activities for manufacturing processes, equipment, and software systems.
• Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
• Facilitate risk management activities to identify and mitigate risks to product quality, safety, and efficacy.
• Support internal and external audits as a Subject Matter Expert for Production & Process Controls.

Requirements

• Bachelor’s degree in engineering, Science, or a related field.
• Minimum of 7 years’ experience in Quality or Engineering.
• Experience in the medical device or pharmaceutical industry.
• Knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR.
• Proficiency in quality tools and methodologies such as Six Sigma, FMEA, and Gage R&R.

Nice to have

• ASQ, CQE, Six Sigma Green Belt, or other applicable certifications.
• Experience with Class III disposable and/or Electro-Mechanical medical devices.
• Project management and leadership experience.

Culture & Benefits

• Comprehensive health, dental, and vision insurance benefits.
• 401k plan with company match.
• Paid Time Off and Parental/Caregiver leave.
• Wellness initiatives and Health Assistance Resources.
• Tuition Reimbursement and Commuter Benefits.