Operational Quality Engineer II - JBL Resources

Our hiring company, a best in class medical device manufacturer has an opening for a Quality Engineer II north of Baltimore on the Delaware border. Holding itself to the highest standards of integrity, quality and excellence, this company has contributed to the healthcare industry for over 100 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 society.
The Quality Engineer II will be responsible for investigating, planning, and implementing improvements in and/or additions to current products and manufacturing processes that directly affects safety, quality, and productivity with the end result of producing a better quality product more efficiently.

Day-to-Day Duties May Include:

• Providing focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities.
• Investigating, identifying, and implementing best-in-class Quality Engineering practices.
• Establishing effective corrective action plans.
• Leading in the implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Acting as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Reviewing and approving product and process qualification and validation and other change control related documentation.
• Developing product/process assurance plans, which include all required elements.
• Identifying and implementing effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
• Generating internal quality documentation such as quality plans, standard operating procedures and inspection procedures.
• Ensuring QA, FDA and ISO compliance in all areas of responsibilities.
• Participating in Product Review Boards.
• Identifying non-conformance trends and developing technical investigation plans.
• Investigating and analyzing customer/internal complaints.
• Performing analytical measurements and experiments to qualify or resolve product and process issues.
• Developing and implementing strategic quality plans, master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements.
• Tracking quality trends and initiating action items to resolve issues. 
• Managing assigned corrective actions.
• Monitoring field quality and analyzing field returns to determine root cause.
• Providing training and support for quality system processes and quality engineering practices.

Qualifications:

• Bachelor’s Degree in Engineering, Engineering Technology, Computer Science, Mathematics, or Physics required.
• 3-7 years’ Manufacturing Quality Engineering experience required.
• 3 years of medical device industry experience.
• Experience working in a manufacturing environment preferred.
• One year of auditor experience preferred.
• Certification as a CQA; CQE or CQM and member of the ASQ is preferred.
• Knowledge of national and international regulations applicable to medical devices including Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC.

Interested Candidates please apply on our website at https://jobs.jblresources.com.
For more information about our services and great opportunities at JBL Resources, please visit our website: https://www.jblresources.com.
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