STAFF QUALITY ENGINEER II (HYBRID

Auctis; Franklin Lakes (NJ); Ibrido; USD 126.600 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Relocation Assistance

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

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

Conoscenze

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

Formazione

BS degree in Engineering or other scientific field

Descrizione del lavoro

Franklin Lakes, NJ, United States Becton, Dickinson, and Company

About the job STAFF QUALITY ENGINEER II (HYBRID

Staff Quality Engineer II (Hybrid)

Location: Franklin Lakes, New Jersey, United States Company: Becton, Dickinson, and Company HR: Mable Farish

Base Salary: USD $126,600 to $130,000
Relocation Assistance: Possible for ideal candidate
Required Experience: 10+ to 15 years
Minimum Education: Bachelor's Degree

Industry:Medical Equipment / Devices
Job Category: Manufacturing - Quality

Description: Join us at Becton, Dickinson, and Company, a global leader in medical technology. As a Staff Quality Engineer II, you'll play a vital role in our Wearable Injector platform, contributing to new product development and maintenance. Bring your expertise in design control, problem-solving, and analytical skills to ensure product quality through processes like validation, measurement system analysis, root cause analysis, and design verification.

Responsibilities:

• Evaluate customer requirements and identify quality standards
• Release products during development activities
• Implement PS global procedures and standards for QE engineering
• Support audits and corrective actions
• Conduct Failure Investigations and problem-solving sessions
• Approve new design/process specifications
• Provide guidance to team members
• Design and perform development independently
• Liaise with Manufacturing Plants
• Define product control strategy and lead risk management activities
• Ensure design control elements are satisfied
• Perform process validation activities
• Evaluate test methods and develop systems related to project quality activities
• Support continuous improvement and customer-facing teams
• Ensure agreement terms are met
• Provide technical support from a quality perspective

Position Requirements:

• Education: BS degree in Engineering or other scientific field
• Experience: Quality Engineering experience or 12+ years in the industry (Medical Device/Pharmaceutical)

Special Skills:

• Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMP
• Knowledge of design control principles
• Statistical methods for Quality Assurance
• Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management
• Knowledge and experience in manufacturing, project management, and engineering
• Good written and oral communication skills
• Excellent problem-solving and analytical skills
• Strong leadership capability
• Ability to handle multiple projects simultaneously in an unsupervised environment

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