Staff Quality Engineer

Integra LifeSciences; Princeton (NJ); On-site; USD 93,000 - 191,000; Full time

Job summary

An established industry player is seeking a Staff Quality Engineer to lead process validation efforts and drive continuous improvement in supplier quality. This role involves ensuring compliance with FDA and ISO standards while collaborating with various stakeholders to enhance product quality. The ideal candidate will have a strong background in quality management, process validation, and data analysis, contributing to innovative healthcare solutions. Join a team that values change as an opportunity and is dedicated to shaping the future of medical technology.

Qualifications

• 10+ years of experience in manufacturing engineering or quality.
• Strong experience in IQ/OQ/PQ and data analytics.
• Medical Device or Pharmaceutical experience is required.

Responsibilities

• Lead process validations and ensure compliance with quality standards.
• Drive continuous improvement initiatives with suppliers.
• Conduct audits and support supplier quality issues.

Skills

Process Validation

Data Analysis

Quality Management

Continuous Improvement

Communication Skills

Education

Bachelor's degree in Engineering or Sciences

Master's degree in Engineering or Sciences

Doctoral degree in Engineering or Sciences

Tools

Statistical Analysis Software

Agile Methodologies

Job description

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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.

This position is for a Staff Quality Engineer, Global Supplier Process Validation with hands-on experience and proven success in Process Validation and driving continuous 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.

• 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 degree or equivalent with 10+ years of experience, Master degree with 8+ years of experience, Doctoral degree with 5+ years of experience in manufacturing engineering, Mechanical Engineering, Industrial Engineering or Sciences.
• Minimum 8 years of experience in quality or manufacturing with bachelor’s degree
• 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 11607 - Sterile Barrier Packaging regulations
• Design History File Navigation: Expertise in navigating and managing Design History Files. Experience with Agile preferred.
• Change Management Process: Expert-level knowledge of change management processes within FDA and ISO 13485 regulatory standards.
• 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.
• Exceptional communication skills, including the ability to clearly articulate complex concepts verbally, draft professional and concise written documentation, and deliver engaging presentations to diverse audiences.

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.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law | EOE including Disability/Protected Veterans

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] or call us at 855-936-2666.

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Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance
• Industries
• Medical Equipment Manufacturing

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