Senior Quality Engineer II - Hybrid (Medical Devices)

Auctis; Franklin Lakes (NJ); Hybrid; USD 126,600 - 130,000; Full time

Benefits offered by this job

Relocation Assistance

Job summary

A global leader in medical technology is seeking a Staff Quality Engineer II to join their team in Franklin Lakes, New Jersey. This hybrid role requires strong engineering expertise and over 10 years of experience in quality engineering within the medical device industry. Responsibilities include ensuring product quality, conducting failure investigations, and support during audits. Ideal candidates will have a BS in Engineering, a solid understanding of regulatory standards, and excellent problem-solving skills.

Qualifications

• 10+ to 15 years of Quality Engineering experience in the medical device or pharmaceutical industry.
• Experience with quality standards such as ISO 13485, QSR, and GMP.

Responsibilities

• Evaluate customer requirements and identify quality standards.
• Conduct Failure Investigations and problem-solving sessions.
• Support audits and corrective actions.

Skills

Knowledge of design control principles

Statistical methods for Quality Assurance

Thorough understanding of industry regulations/standards

Excellent problem-solving skills

Strong leadership capabilities

Good written and oral communication skills

Education

BS degree in Engineering or other scientific field

Job description

A global leader in medical technology is seeking a Staff Quality Engineer II to join their team in Franklin Lakes, New Jersey. This hybrid role requires strong engineering expertise and over 10 years of experience in quality engineering within the medical device industry. Responsibilities include ensuring product quality, conducting failure investigations, and support during audits. Ideal candidates will have a BS in Engineering, a solid understanding of regulatory standards, and excellent problem-solving skills.