Senior Supplier Quality Validation Engineer

INTEGRA LIFESCIENCES SALES LLC; Kingston (NJ); On-site; USD 109,000 - 150,000; Full time

Job summary

Integra LifeSciences is seeking a Staff Engineer - Supplier Quality Validation Engineer in New Jersey with hands-on experience in IQ/OQ/PQ validation to drive continuous improvement and supplier quality across surgical and tissue technologies divisions.

The role requires 10+ years in manufacturing/quality, strong English communication, and experience with FDA/ISO quality systems; travel up to 10% is possible; there is potential for collaboration across multiple departments and external suppliers.

Qualifications

• Bachelor's degree or equivalent with 10+ years of experience; master's with 8+ years; Doctoral with 5+ years in manufacturing engineering, quality or relevant engineering degree.
• Fluent in English with strong communication skills; experience in process validation and data analytics.
• Medical Device or Pharmaceutical experience required.
• ISO 9001 and ISO 13485 knowledge preferred.
• Travel up to 10% with possible international travel.
• Experience in FDA and other regulatory controlled environments.
• Strong collaboration skills and experience in a matrix environment.
• Ability to read and understand technical and statistical documents.
• Knowledge of current Good Manufacturing Practices (cGMP) and other applicable standards.
• Experience using analytical tools to drive data-based decision making.

Responsibilities

• Coordinate communication, verification and execution of process validations for supplier processes.
• Ensure IQ/OQ/PQ requirements and protocols are communicated, completed, and verified for each group.
• Drive continuous improvement in supplier quality processes through data analysis.
• Lead for-cause audits to determine root cause and drive CAPAs.
• Support supplier quality teams with supplier visits and audits as needed.
• Review and approve qualification documentation (IQ/OQ/PQ) with suppliers for new products and LCM projects.
• Promote behaviors supporting continuous improvement to meet short- and long-term objectives.

Skills

Quality management concepts

IQ/OQ/PQ validation

Data analytics

Communication skills

Collaboration skills

Reading technical documents

Education

Bachelor's degree or equivalent

Master's degree

Doctoral degree

Job description

Integra LifeSciences is seeking a Staff Engineer - Supplier Quality Validation Engineer in New Jersey with hands-on experience in IQ/OQ/PQ validation to drive continuous improvement and supplier quality across surgical and tissue technologies divisions.

The role requires 10+ years in manufacturing/quality, strong English communication, and experience with FDA/ISO quality systems; travel up to 10% is possible; there is potential for collaboration across multiple departments and external suppliers.