Global Supplier Quality Engineer II – Medical Device (Hybrid)

Integra LifeSciences; New Jersey; On-site; USD 71,000 - 98,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan

Bonus potential

Job summary

Integra LifeSciences is seeking a Global Supplier Quality Engineer II to lead supplier quality programs at the Plainsboro, NJ site. The role conducts supplier audits and maintains supplier quality requirements across contract manufacturers and raw material suppliers, with emphasis on cGMP, ISO 13485, and 21 CFR 820.

The position is hybrid, requiring onsite work at least 3 days per week in Plainsboro, NJ, and involves collaboration across QA, purchasing, and production teams to ensure

Qualifications

• Bachelor's or master's degree in manufacturing engineering, mechanical engineering, industrial engineering or sciences or a related discipline.
• Minimum 3 years of experience in quality or manufacturing.
• Medical Device or Pharmaceutical experience is required.
• Experience or knowledge of ISO 9001 and ISO 13485, 21 CFR 820 preferred.
• Travel up to 25% with possibility of international travel.
• Experience in FDA and other regulatory controlled environments.
• Strong collaboration in a matrix environment.
• Ability to read and understand technical and statistical documents.

Responsibilities

• Establishes and maintains the Approved Supplier List.
• Plans and executes supplier audits.
• Conducts supplier audits per GMP, ISO, and regulatory requirements.
• Ensures measurement systems monitor supplier quality and prevent defects.
• Maintains Supplier Quality Agreements with applicable suppliers.
• Supports QC, purchasing, and production with technical guidance.
• Provides QA support to suppliers including CAPA and change management.

Skills

Quality engineering

ISO 13485

FDA CFR 820

cGMP

Auditing

Data analysis

Education

Bachelor's or Master's in Manufacturing/Industrial/Mechanical Engineering or related

Job description

Integra LifeSciences is seeking a Global Supplier Quality Engineer II to lead supplier quality programs at the Plainsboro, NJ site. The role conducts supplier audits and maintains supplier quality requirements across contract manufacturers and raw material suppliers, with emphasis on cGMP, ISO 13485, and 21 CFR 820.

The position is hybrid, requiring onsite work at least 3 days per week in Plainsboro, NJ, and involves collaboration across QA, purchasing, and production teams to ensure