Staff Quality Engineer

This position is for a hands-on Supplier Quality Validation Engineer with proven success in Process Validation and driving continuous improvement with suppliers. The role ensures timely completion of process validation requirements for new products and life cycle change management (LCM) projects, adhering to defined program and company standards.

About the role

The ideal candidate will demonstrate proficient experience with quality management concepts, IQ/OQ/PQ process validation, and manufacturing engineering to drive continuous improvement. They will act as a liaison between the organization and suppliers to lead and communicate component/process validation requirements, ensuring timely completion and verification.

Responsibilities

• Communicate, verify, and execute process validations of supplier processes for products procured and used by Integra’s Codman Specialty Surgical and Tissue Technologies divisions.
• Ensure supplier process validation requirements (CTQs, drawings, specifications, FAIs) and protocols for IQ/OQ/PQ are communicated, completed, and verified for each responsible group.
• Drive continuous improvement in supplier quality processes through data analysis and identification of areas for improvement.
• Perform for-cause audits to determine root cause and drive CAPAs while supporting site supplier quality teams.
• Lead critical Supplier Quality-related issues, including supplier visits and audits.
• Review and approve executed qualification documentation (IQ/OQ/PQ) with suppliers for new product and LCM projects.
• Develop and promote behaviors to sustain a culture of continuous improvement supporting short- and long-term business objectives.
• Support the supplier consolidation initiative.
• Provide and develop training on Process Validation concepts for the team and organization as needed.
• Utilize coaching and facilitating skills with program stakeholders to ensure proper project management, expectation setting, and best practices.
• Direct GSQ department activities to ensure compliance with regulations and standards, including FDA, ISO 13485, CMDR, MDR, 21 CFR Part 11, and IQ/OQ/PQ.
• Interact and coordinate activities with other departments, external vendors, and customers.
• Influence and collaborate across stakeholder groups to identify and implement process/continuous improvement opportunities.

Requirements

• Bachelor’s degree or equivalent with 10+ years of experience, master’s degree with 8+ years, or doctoral degree with 5+ years in manufacturing engineering, Mechanical Engineering, Industrial Engineering, Quality, or a relevant engineering field.
• Fluent in English with strong communication skills.
• Strong experience in process validation and component qualification (IQ/OQ/PQ) and data analytics.
• Medical Device or Pharmaceutical experience is required.
• Experience or knowledge of ISO 9001 and ISO 13485 requirements preferred.
• Travel up to 10% with a possibility of international travel.
• Experience in FDA and other regulatory-controlled environments.
• Strong collaboration skills and experience working in a matrix environment.
• Ability to read and understand technical and statistical documents.
• Ability to interface with technical and non-technical personnel.
• Knowledge of current Good Manufacturing Practices (cGMP) and other applicable standards.
• Experience using analytical tools to drive data-based decision-making.

Pay

Salary range: $109,250.00 – $149,500.00 USD. Individual pay is determined by job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity, or other variable compensation.

Benefits

• Medical, dental, and vision insurance.
• Life insurance, short- and long-term disability, and business accident insurance.
• Group legal insurance.
• Savings plan (401(k)).