Engineer, Associate in N Barrington, Illinois at Medical Murray

Position Summary:
The Associate R&D Quality Assurance Engineer position works within the Quality Department to support development project deliverables and contribute to R&D efforts from concept to production for disposable medical devices including catheters, catheter-based delivery systems, and other disposable devices for disciplines ranging from cardiology and neurology to urology. This position will work with high-performance cross-functional teams to develop products that meet the company objectives to provide goods and services that meet customer’s requirements for quality, quantity, and timeliness.

Essential Duties and Responsibilities:

• Understand internal and external quality and regulatory standards and requirements
• Represent Quality on development teams to ensure compliance with quality management system and applicable regulatory requirements and standards
• Partner with R&D to determine and implement design controls based on risk management, customer needs and requirements, and manufacturability considerations
• Develop and update Design History Files on behalf of the customers
• Create and maintain Quality Plans for development projects
• Contribute to risk management activities compliant with ISO 14971
• Review and provide input to design and manufacturing documentation including material specifications, drawings, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured
• Develop and optimize quality control inspection documentation, including inspection procedures and forms, and sample sizes based on critical design attributes, risk levels, and statistical rationale. Ensure suitable metrology is used
• Perform inspections on manufactured products
• Assist in creating test protocols, then perform and document testing according to those protocols. This includes design verification and validation testing, lot release testing, test method validation, measurement repeatability and reliability, process validation, etc.
• Train technicians and inspectors as needed
• Participate in report creation
• Review and approve lot history records and other quality records and project documentation to ensure compliance
• Contribute to and review nonconformance reports, temporary deviation orders, corrective and preventative action reports, and other quality records
• Ensure design input/output documentation is complete and compliant, and that design and development activities are compliant with the quality management system
• Monitor customer’s regulatory submission questions, compliance questions, and audit results, and proactively communicate lessons learned internally. Assist in writing responses for product and quality system-related questions
• Apply systematic problem-solving methodologies in identifying, analyzing, prioritizing, communicating, and resolving quality issues, including root cause investigations
• Support the customer complaint process for R&D and evaluate returned product
• Participate in supplier selection process and define incoming inspection criteria and sampling requirements
• Monitor suppliers and quality of materials and services provided
• Assist in internal and external audits of the quality system
• Provide general quality support as required by management
• Direct billing % above 70%
• Demonstrate understanding of D&D process by leading and executing full project deliverables to satisfy customer expectations

Minimum Qualifications:

• BS or MS in an engineering discipline or equivalent experience
• 0 – 2 years of experience in Quality Engineering or R&D engineering for medical devices
• Experience in the area(s) of ISO and FDA Quality Systems preferred
• Experience with design control and establishment of design history files desired
• Green Belt Certification desired

Knowledge, Skills, Abilities:

• Knowledge and understanding of ISO-13485, ISO-14971, and FDA 21 CFR Part 820 cGMP standards
• Technical skills must include medical device testing, protocol writing, and report writing
• Knowledge of statistics, for example, data analysis and SPC
• Computer skills needed include Microsoft Office or equivalent
• Strong analytical and problem-solving skills
• Excellent verbal and written communication skills

Equal Opportunity Employer

Medical Murray is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.