Senior Quality Engineer
Location: Wilmington, Delaware
About Our Client:
Our Hiring Company, a best-in-class Medical Device Manufacturer has an opening for a new team member at their facility. Holding itself to the highest standards of integrity, quality and excellence, this company has contributed to the healthcare industry for over 90 years and has been rated as Forbes top 14 most innovative companies in the world. With a strong vision for making medical treatments easier on its patients, this company gears its technological innovations from its top-talented engineers towards making a significant contribution to our society.
Key Responsibilities:
- Investigating and implementing best-in-class Quality Engineering practices across the organization.
- Providing quality engineering support for development projects to ensure timely and effective execution.
- Establishing corrective action plans and leading quality assurance efforts, process controls, and CAPA systems.
- Acting as a leader or active team member in supporting quality decisions and practices.
- Applying systematic problem-solving methods to identify, prioritize, and resolve quality issues.
- Reviewing and approving product and process qualifications, validations, and change control documentation.
- Developing product/process assurance plans and implementing process control systems.
- Generating internal quality documentation, including quality plans, SOPs, and inspection procedures.
- Participating in Product Review Boards and investigating customer/internal complaints.
- Performing analytical measurements and experiments to qualify or resolve product and process issues.
- Developing and implementing strategic quality plans and validation protocols to meet FDA and ISO requirements.
- Tracking quality trends and managing corrective actions to address root causes.
- Monitoring field quality and analyzing field returns to identify and resolve systemic issues.
- Providing training and support for quality system processes and engineering practices.
Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- 6-10 years of progressively responsible experience in a medical device quality assurance environment.
- 1-2 years of auditor experience is preferred.
- Strong verbal and written communication skills.
- Excellent organizational and time management abilities.
- Preferred certifications include CQA, CQE, or CQM; ASQ membership is a plus.
- Proficiency with computers and standard software applications.
- Strong writing, mathematics, and statistics skills.
Interested Candidates please apply on our website at .
For more information about our services and great opportunities at JBL Resources, please visit our website: .
JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.
JBL is an Equal Opportunity Employer and E-Verify Company