Staff Quality Engineer
Staff Quality Engineer
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Salary Not Disclosed
1 Vacancy
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 whats 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 handson 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.
To perform this job successfully an individual must be able to perform each essential duty satisfactorily.
- Responsible for communication verification and 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 forcause 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 longterm 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:
The requirements listed below are representative of the knowledge skill and experience required for this position.
- 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 bachelors 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: Expertlevel 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 nontechnical personnel.
- Knowledge of current Good Manufacturing Practices (cGMP) and other applicable standards.
- Experience using analytical tools to drive databased 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.
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Required Experience:
Staff IC
Employment Type
Full-Time
