Job Overview The Senior Quality Engineer is responsible for implementation and execution of Quality Engineering functions, ensuring the effective establishment and maintenance of quality systems.
Job Responsibilities and Essential Duties - Leads quality planning by ensuring assigned quality plans and necessary gap assessment are documented, effective, and completed on time.
- Leads Quality management activities, which includes ensuring that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time.
- Run the Material Review Board Meeting by providing and/or reviewing data to be presented for escalations of non-conforming material records.
- Supports Supplier management, which includes non-conforming material review and supporting incoming material inspection.
- Coordinates technical activities regarding validations: including protocol development, synchronization of interdepartmental activities, evaluation, and reporting results.
- Leads communications, interacts, and coordinates quality improvement efforts with Manufacturing, QA, R&D, and engineering management regarding product status, deviations, and problems; provides testing and training support to Manufacturing, Engineering and R&D
- Reviews and approves product/process qualification/validation and other change control related documentation.
- Identifies and leads implementation of new opportunities for improvements to work processes, production, QA testing, and other areas as identified.
- Investigates product issues by conducting failure investigations within the NCMR process.
- Facilitates the investigation of component issues with Engineering, as needed.
- Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee
- Lead and support CAPA related activities.
- Provide mentorship and guidance to new Engineers/Interns within the organization.
Required Knowledge, Skills, and Abilities - Bachelor's degree in engineering, Science or equivalent is required. A Master of Science in Engineering, Science or equivalent is preferred. CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is desirable.
- A minimum of five years' experience in quality assurance, quality engineering or related functions or a M.S. plus 3 years' experience is required. Prior experience in an FDA regulated industry or ISO certified organization
- Must have demonstrated proficiency in statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across departments.
- Working knowledge of quality systems is required. Familiarity with analytical software applications is preferred.
- Project management and leadership experience is required. Previous experience supervising technicians and conducting and participating in FDA/customer/corporate audits is preferred.
- Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
- Knowledge of Microsoft Office Products such as Word, Excel or equivalent software applications
The base salary for the position is a minimum of $115, 000 and a maximum of 120,000 plus an annual bonus of 10%
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