Senior Quality Engineer (Direct Hire)
Job Requisition: 6464
Description for Sr. Quality Engineer:
This position will report to the Regional Quality Manager. The Senior Quality Engineer will be responsible for validations, scrap reduction and continuous improvement activities. Will ensure that projects are implemented, internal/external quality issues are investigated, and root cause and corrective/preventive actions are identified and executed.
Responsibilities for Sr. Quality Engineer:
New Product Development
- Participate in Design Reviews, including Technical Reviews, Feasibility Discussion, and Failure Modes and Effects Analysis (FMEA) creation
- Assist in documenting development work including supporting writing specifications for manufacturing or identifying and/or evaluating scientific test results
- Manage Implementation and Documentation of IQ, OQ, PQ.
- Ensure timely and conclusive validations.
- Update existing inspection plans, test methods, and standard operating procedures
- Conduct sample size determination, statistical analysis, training, and root cause analysis
- Take lead in understanding/updating FMEA for new failure modes
- Assist in process optimization
- Drive and Actively contribute to various manufacturing projects such as process development, cost reduction and quality improvement initiatives
- Perform routine engineering assignments of related tasks which are typically a focused portion of larger projects.
- Lead cross-functional teams in continuous quality improvement projects, in particular, in scrap reduction and identification and elimination of non-value-added activities
- Take lead in collection, review, analysis and trending of quality indicators for monthly and quarterly reviews
- Manage and contribute to problem solving teams using standardized investigation processes/tools.
- Participate in the Internal Audit process and assist in addressing observations
- Participate in customer and regulatory body audits
Requirements for Sr. Quality Engineer:
- Bachelor’s degree (required) in Biomedical Engineering field (desired).
- 5+ years related experience (required) preferably within the Medical Devices Industry
- Ability to perform routine design and engineering tasks with some assistance.
- Solid understanding of engineering and mathematics principles.
- Ability to interpret product requirements from drawings, specifications, blueprints, etc. and to identify and drive corrections of inconsistencies or inaccuracies in same
- Able to command use of inspection and measuring instruments such as calipers, micrometers, and tensile strength testers
- Highly motivated, detail-oriented, eager to drive needed change in the organization
- Demonstrated use of strong analytical, problem solving, and teamwork skills in a leadership role
- Able to follow and to provide instructions in all formats: written, verbal, and electronic.
- Excellent time management, prioritization abilities, and strong project management skills
- Ability to develop, implement, and present strategies to gain support
- Strong analytical skills, with 80/20 mindset
- Ability to work with and manage complexity/change such that implementation is simplified
- Demonstrated ability to analyze data and make sound, enterprise-first, decisions
- Excellent interpersonal, communication, and presentation skills
- Ability to generate respect and trust from staff and external constituencies along with the ability to work collaboratively with colleagues and staff to create a results-driven, team-oriented, profitable environment
- Personally driven and able to motivate others to excel
- Ability to use MS Office Tools such as Word, Excel, Project, Access and MiniTab®.
Desired for Sr. Quality Engineer:
- Plastic Injection Molding experience
- 8D Problem solving
- ISO 13485 knowledge