job summary: **IMMEDIATE DIRECT HIRE NEED
We are looking for a Senior Quality Engineer
who will ensure product compliance to 21 CFR Part 820, ISO 13485:2016, ISO 14971:2007/2019, MDD 93/42/EEC and EU MDR 22017/745 and 746. Collaborate with cross-functional teams to maintain adherence to the Quality Management System during planning, execution and implementation activities for Engineering initiatives. Lead the development and application of risk management activities ensuring patient and user safety by identification of risk-driven product requirements.**
location: Cincinnati, Ohio
job type: Permanent
salary: $90,000 - 95,000 per year
work hours: 9 to 5
- Support New Product Development, Sustaining, and cost-saving projects by ensuring compliance of project activities and documentation to internal QMS requirements as well as external regulations and standards (FDA, ISO, EN).
- Provide assessments and review for planning, execution and implementation of design and manufacturing changes for commercialized products.
- Drive design assurance into medical devices as the Quality Lead during all stages of design controls projects through support of user needs, product requirements, design specifications, design verification and validation strategies, usability studies, and design reviews.
- Responsible to generate and independently maintain project risk management file for NPD and sustaining projects. These include risk plans, hazard/failure mode effects analysis, risk mitigations and effectiveness checks, and risk management reports using principles from ISO 14971.
- Assist supplier quality, CMO, manufacturing, marketing and other stakeholders to generate risk assessments using Design, Process, Software FMEAs, FTAs, etc. per requirements of ISO 14971.
- Improve customer interfacing of products by direct analysis of impact through risk evaluation and prioritization of use errors per FDA's and IEC 62366 Human Factors and Usability Engineering for Medical Devices.
- Provide expertise in development and implementation of C/R strategy, statistical support, inspection, sampling plans, test methods during Design Verification and Validation using a risk-based approach.
- Assist with annual post market surveillance activities, ensures effective maintenance of the risk management program for commercialized products, and assess the need to implement design and process changes, where needed.
- Own applicable corporate quality policies and drive updates based on new standards or regulations for compliance, and/or process improvements for efficient use of QMS.
- Support product End of Life activities.
- Assist in training company employees, other Design Assurance QEs on the principles of Quality and other QMS elements
- Apply technical problem-solving methodologies to identify, adapt to shifting priorities, communicate, and resolve quality issues.
- Assist with internal and external audits that include FDA, ISO and MDSAP.
- Provide assessment to resolve deviations and contribute to root cause investigations using various problem-solving techniques and tools for NCEs, CAPAs, Field Actions, Health Hazard Evaluations, and assesses effectiveness of corrective actions.
- Bachelor's degree in a technical field (i.e., Biomedical Engineering, Mechanical Engineering, Material Science Engineering, Physical Sciences) plus 5 years related work experience; OR, Master's degree plus 3 years related work experience required.
- Experience in the medical device industry (manufacturing, engineering, or technical capacity) required.
- In-depth knowledge and experience of 21 CFR Part 820 and ISO 13485 Design Controls required.
- FDA Class I and/or II medical device experience
- Medical device software experience preferred.
- Professional certifications (i.e., CQE, Six Sigma)
skills: Quality control, Quality Assurance, Medical Device Product Development
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.