Staff Quality Engineer

Integra LifeSciences; Añasco (PR); On-site; USD 73,000 - 102,000; Full time

Job summary

Integra LifeSciences seeks a Staff Engineer - Supplier Quality Validation Engineer to lead supplier process validations (IQ/OQ/PQ) and drive continuous improvement. You will liaise across divisions to ensure quality standards and regulatory compliance. The role requires strong data analytics and cross-functional collaboration, with travel up to 10%.

Qualifications

• Bachelor's degree or higher with 10+ years in manufacturing/engineering.
• Experience with IQ/OQ/PQ process validation and data analytics.
• Medical device or pharmaceutical experience required.
• ISO 9001/ISO 13485 knowledge preferred.
• Travel up to 10% with possible international travel.

Responsibilities

• Coordinate and verify supplier process validations (IQ/OQ/PQ).
• Drive continuous improvement in supplier quality processes through data analysis.
• Lead audits and CAPAs for supplier-related issues.
• Review qualification documentation for new products and LCM projects.
• Ensure compliance with FDA, ISO 13485, CMDR, MDR and 21 CFR Part 11.

Skills

Process validation

Data analytics

IQ/OQ/PQ

Supplier quality

English fluency

Education

Bachelor's degree in engineering

Master's degree in engineering

Doctoral degree in engineering

Tools

ISO 9001 knowledge

ISO 13485 knowledge

cGMP knowledge

Job description

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Job Description

This position is for a Staff Engineer - Supplier Quality Validation Engineer with hands-on experience and proven success in Process Validation and driving cont. improvement with suppliers. This position will be primarily engaged to ensure timely completion of process validation requirements of new products and life cycle change management (LCM) projects with suppliers to the required quality standard in accordance with defined program and company requirements. The ideal candidate should demonstrate proficient experience with quality management concepts, IQ/OQ/PQ process validation and manufacturing engineering to drive continuous improvement. The candidate will act as liaison between the organization and the supplier to lead and communicate the component/process validation requirements and ensure timely completion and verification of the activities.

Responsibilities

• Responsible for communication, verification and execution of process validations of supplier processes that involve products procured and used by Integra for the Integra Codman Specialty Surgical and Tissue Technologies divisions.
• Ensure supplier Process validation requirements (CTQs, drawings, specifications, FAIs etc.) and protocol 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 the site supplier quality teams.
• Provide support to sites by leading critical Supplier Quality related issues which may require supplier visits and audits.
• Review and approve executed qualification documentation (IQ/OQ/PQ) with suppliers for new product and LCM projects.
• Develop and promote the right behaviors to sustain a culture of continuous improvement necessary to support both short- and long-term business objectives.
• Support the supplier consolidation initiative.
• Provide and develop training on the Process Validation concepts to the team and organization, as needed.
• Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized.
• Direct the activities of the GSQ department to ensure compliance with all appropriate regulations and standards, including FDA, ISO 13485, CMDR, MDR, 21 CFR Part 11 & IQ/OQ/PQ.
• Interact and coordinate activities with other departments, external vendors, and customers. Influences and collaborates across stakeholder groups in the areas of process / continuous improvements, identify and implement opportunities.

Qualifications

• Bachelor's degree or equivalent with 10+ years of experience, master's degree with 8+ years of experience, Doctoral degree with 5+ years of experience in manufacturing engineering, Mechanical Engineering, Industrial Engineering, Quality or relevant engineering degree.
• 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 environment.
• 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.

Salary Pay Range:

$73,000.00 - $102,000.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including 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. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [e-mail].