Senior Quality Engineer – MedTech NPI & GMP

6029-MEDICAL DEVICE BUSINESS SERVICES, INC. Legal Entity

Monet (FL)

On-site

USD 85,000 - 120,000

Full time

10 days ago

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Job summary

Johnson & Johnson is seeking a Senior Quality Engineer for the DePuy Synthes Quality organization in Palm Beach Gardens, FL. You will lead quality assurance activities in on-site manufacturing, ensuring GMP and ISO compliance while supporting New Product Introduction and Value Improvement projects.

The role requires a Bachelor’s in Engineering or Life Sciences, 2–4 years in regulated environments, and strong problem solving and communication skills. Travel is under 10%.

Qualifications

Bachelor's degree required.
2–4 years of related work experience in regulated industries.
Professional quality or Manufacturing Engineering experience.
In-depth knowledge of product/process Risk Management (MDSAP, MDD, MDR, FDA and ISO standards).
Experience implementing risk mitigation and strong communication/teamwork skills.

Responsibilities

Provides quality system design and audit support for product teams.
Ensures compliance with GMP, ISO, and related standards in daily operations.
Addresses and corrects product and process complaints.
Reports on contract manufacturer performance metrics and management reviews.
Oversees audits of quality system categories to ensure process excellence.

Skills

GMP

ISO standards

Risk management

Quality systems

Communication

Problem solving

NPI process

Education

Bachelor's degree in Engineering, Life Science, or related field

Job description

The role requires a Bachelor’s in Engineering or Life Sciences, 2–4 years in regulated environments, and strong problem solving and communication skills. Travel is under 10%.

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