10 senior quality engineer Jobs in southaven, ms
Vakulatech is Hiring a Sr Quality Engineer Near Southaven, MS
Job Description
- Ensure that manufacturing processes comply with quality standards performing follow-ups and monitoring the Notifications generated, process validations, post market complaint analysis and defect trends, in accordance with international industry practices and regulations (ISO 13485, 21CFR820); to meet the objectives of the quality department, providing support in corrective and preventive actions (CAPAS) and implementing actions that generate defect reduction.
- Develop, implement, maintain and improve appropriate quality system elements to ensure a degree high product quality and continuous improvement.
- Provide Quality Engineering support for, NPI, Sustaining activities and improvement projects.
- Own and/or support Quality Notifications (Non-Conformance events), Correction and Preventive Actions (CAPA) as needed and assigned.
- Assess Manufacturing and Design changes against their impact and support the implementation of such changes.
- Support Post Market in the analysis of Complaint data and RMAs Failure Analysis investigation.
- Collect, analyze, and trend product quality data and provide reports to management on progress or escalation.
- Author test protocols/reports (MVPs, IQ/OQ/PQ, Engineering reports) and execute qualification and validation testing as needed.
- Address product quality issues and approve material dispositions.
- Support Internal and External audits.
- Design and implement Quality System processes, procedures, and techniques such as risk assessment, root cause analysis, etc.
- Interface with other engineering departments, manufacturing sites, customers, and suppliers on quality related issues in a timely manner
- Minimum Education: 4-year degree in STEM. Engineering degrees are preferred.
- 6 years of related work experience in a regulated industry or a minimum 4 years with a master's degree.
- Preference for Electro-Mechanical Medical Device experience
- Experience in Quality, Manufacturing, or Research and Development experience in a medical device or other regulated industry.
- Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations (i.e., Root Cause Problem Solving).
- Ability to apply project management skills to ensure fulfillment of new product development requirements.
- Ability to develop and implement Quality standards.
- Demonstrated auditing and problem-solving skills.
- Strong knowledge of Quality Engineering, design control, and verification and validation (V&V) tools and methodologies.
- Ability to effectively communicate with internal and external personnel at all levels of the organization.
- Well-developed influencing and negotiation skills.
- Ability to effectively train and mentor a diverse array of employees at all levels of the organization.
- Strong understanding of Six Sigma and Process Excellence tools and methodologies.
Job Summary
Full Time
$113k-134k (estimate)
06/28/2024
07/15/2024
The following is the career advancement route for Sr Quality Engineer positions, which can be used as a reference in future career path planning. As a Sr Quality Engineer, it can be promoted into senior positions as a Quality Assurance Engineering Supervisor that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Sr Quality Engineer. You can explore the career advancement for a Sr Quality Engineer below and select your interested title to get hiring information.
