Cresilon, Inc is a medical device company based out of Brooklyn, NY that focuses on bringing new technologies to the animal health industry that aim to solve problems associated with wound healing. We have created a hemostatic device that can instantly stop traumatic bleeding.
Please refer to these associated links to learn more about Cresilon:
The Quality Engineer fosters change and risk-based decision-making. The Quality Engineer supports all new development activities and associated manufacturing processes and actively participates in continuous improvement and support activities of existing products. This individual develops and improves on risk assessment, inspection methodology and acceptance criteria for inspection sample plans and conducts audits of new suppliers as part of the project teams. The Quality Engineer communicates effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory Affairs and Manufacturing. The Quality Engineer adopts and maintains a culture of excellence and quality in all aspects of his/her job function. The Quality Engineer works in a highly regulated environment and aids in ensuring that the Quality Management System methods and Quality System Regulations are applied throughout Cresilon.
- Attempt to "break" the product under development, and report experiences, successes, and failures to the team to use in future iterations or versions.
- Participate in product realization efforts, including Design Verification & Validation.
- Participate in risk analysis activities at different phases of products development, production and commercialization. Monitor risk management activities
- Participate in risk planning, risk analysis, design controls, verification and validation, and inspection methods and procedures.
- Evaluate and approve of contract-manufacturers/suppliers.
- Participate in conducting suppliers’ audits as required.
- Ensure that vendor’s PFMEAs are compliant with ISO 13485 and FDA cGMP requirements.
- Help develop, qualify, and validate methods of inspection, testing, and evaluation in coordination with Quality Control, as applicable.
- Help establish internal and external inspection requirements.
- Review, approve, and implement inspection plans.
- Support product design transfers to contract-manufacturers/suppliers.
- Participate in the review and approval of Engineering Change Orders and the review and approval of detailed drawings.
- Analyze customer complaints to determine root cause. Participate in handling MDRs.
- Use creative problem-solving skills to identify, solve and/or improve process anomalies.
- Review collected data and trends to make them available for the periodic update of product Risk Management.
- Participate in maintaining and monitoring the following quality systems and supporting documentation: Audit system, CAPA system, FDA QSRs system and ISO 13485 system.
- Review, update, and implementation of procedures affecting quality assurance.
- Review of external reference documents related to the company Quality Management System to ensure that necessary updates are applied to the company procedures and implemented.
- Develop internal training sessions on quality and compliance / conformance issues as necessary.
- Devise sampling procedures and directions for recording and reporting quality data
- Review the implementation and efficiency of quality and inspection systems.
- Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality.
- Analyze data to identify areas for improvement in the quality system.
- Other duties may be assigned as deemed necessary by the supervisor.
- Bachelor's degree in Science, Quality Assurance, Engineering or related scientific discipline.
- Working knowledge of ISO 13485, FDA 21 CFR 820, and ISO 14971.
- Complete understanding of GMP and GLP.
- Experience working in Quality Assurance / Quality Control in a medical device manufacturing environment.
- Experience with drafting and reviewing change control, IQ, OQ, PQ, verification, and validation protocols.
- Experience with investigations, root cause analysis and CAPAs.
- Experience with software validation.
- Ability to draft and review SOPs, which comply with internal and external standards.
- Excellent problem solving and analytical skills.
- Excellent verbal and written communication and presentation skills.
- Proficient in the use of Microsoft Excel and Microsoft Word.