Senior Operations Quality Engineer

Job Title: Senior Operations Quality Engineer

Department: Operations Quality

Reports to: Quality Director

About Us:

We are a contract manufacturer offering medical device prototyping, development, and manufacturing. Our primary capabilities are balloon catheters, delivery systems, reinforced and steerable catheters, nitinol components, and biomedical textiles.

Job Summary: 

Support the Quality Management System (QMS) organization. Work with design and manufacturing teams, leading operations quality activities. Assignments include use of quality engineering concepts including, but not limited to, design control, process control, risk management, supplier quality, root cause analysis, statistical analysis, and continuous improvement activities. Ensure desired design and product performance requirements are met in compliance with applicable regulatory, customer, and internal requirements. Skills in other technical areas such as verification testing, and sterilization validation are desired. Engage in routine daily activities such as First Article Inspections (FAI), CAPA, NCMR, change order review, and training. 

Key Responsibilities:

• Function as the operation’s quality representative during the execution of engineering projects.
• Responsible for ensuring product development projects and changes to existing products are conducted in compliance with the Quality System Regulations.
• Management of NCMR system and reports.
• NCMR and CAPA investigation and reports, including trouble shooting manufacturing problems and ensuring requirement compliance. Collaborate with suppliers on NCMRs and suppler CAPAs.
• Participate in and often lead cross-functional teams for the review and disposition of nonconforming products or components.
• Participate in cross-functional teams to develop and maintain Product Risk Management Files (Risk Management Plan, Risk Assessments, DFMEA, PFMEA, and Risk Management Report).
• Prepare and review documentation with a high degree of accuracy, completeness, and effectiveness.
• Participate in the development of Design Verification and Validation test plans / protocols and Process Verification and Validation test plans / protocols. Provide guidance on Product Requirements compliance.
• Provide guidance and direction for sample size and statistical analysis of Verification and Validation testing.
• Participate in Design Reviews and FMEA Reviews.
• Lead or participate in complaint management and investigation. Ensure investigations are thoroughly documented.
• Provide direction to project teams on all Quality Policies / Procedures (including verification, validation, statistical methods, and design controls), when necessary.
• Training for Special Work Orders, Receiving Inspection Processes, and FAIs as required.
• Lead and train Operations Quality Engineers as required.
• Support internal and supplier audit programs.
• Other duties as assigned.

Qualifications:

• Requires a B.S. degree in Science, Engineering or Technology or associated fields.
• Working knowledge of medical device regulations (FDA 21CFR820, ISO 13485, ISO 14971).
• Working knowledge of new product design and development in medical devices.
• Working knowledge of the application of risk management, include PFMEA.
• Excellent organizational and interpersonal skills working in cross-functional teams.
• Ability to organize and prioritize workflow across multiple projects to meet established time frames and schedules.
• Extensive knowledge of manufacturing operations, process verification and validation, and geometric design and tolerance (GD&T) including the ability to read and understand prints and specifications
• 8+ years’ experience in Quality Assurance, including quality systems, standards, metrics, and tools.
• 8+ years’ experience in the medical device industry.