Senior Quality Engineer I

About the role

The Senior Quality Engineer is instrumental in establishing and upholding quality control measures throughout our product and process development lifecycle, and production activities to ensure manufacture of high quality and reliable products. This role entails close collaboration with Engineering & Production teams to create and execute impactful quality assurance strategies from the initial receiving phase to the release of the final product. This role includes oversight and management of quality inspections as well as equipment calibration, qualification and maintenance. The Senior Quality Engineer's responsibilities fall under four main areas: Management, development and validation of internal inspection processes, metrology and equipment. Evaluation of inspection and measurement systems, metrology techniques, and tooling using statistical measurement system analysis methods. Collaborating with cross-functional teams and suppliers to implement solutions, lead quality improvement initiatives and problem-solving efforts. Management and oversight of quality inspections as well as equipment calibration and qualification. The Senior Quality Engineer will assist in the management and implementation of the Quality Management System to ensure compliance with ISO 13485 and the FDA's Quality Management System Regulation 21 CFR Part 820. The Senior Quality Engineer will provide additional support to the Quality Management System's activities as assigned at the discretion of management. This position is designated as a full-time on-site role and is expected to be performed primarily at the Company's assigned work location. Any work-from-home, hybrid, telecommuting, or other flexible work arrangement is available only if approved under applicable Company policies and business needs, and may be modified, suspended, or discontinued by the Company at any time, consistent with applicable law. Reports to: Vice President of Quality Assurance & Regulatory Affairs. Duties and Responsibilities: The Senior Quality Engineer's responsibilities typically involve: Work closely with the Engineering & Production teams to develop best practices and improve metrology and inspection techniques for product development, manufacturing processes, equipment and fixtures. Evaluate inspection, measurement, and test equipment, metrology techniques, and tooling to ensure suitability for intended use and compliance with quality and regulatory requirements. Plan, execute, and interpret Measurement System Analysis (MSA) studies, including Gage Repeatability and Reproducibility (Gage R&R), Gage Linearity, and Gage Bias studies for capability and identify sources of variation related to equipment, methods, operators, or environment. Collaborate with the Engineering & Production teams to establish necessary controls and verification/validation procedures for production processes. Develop and implement manufacturing process controls, including in-process inspections and sampling plans for receiving in-process, and final inspection. Responsible for supporting Engineering & Production with problem solving, process improvements and resolution to product development and manufacturability issues. Review Engineering drawings and changes to assure that they are properly dimensioned and conform to GD&T protocol and provide proper inspectability for the related components and assemblies. Evaluation of changes to design and/or manufacturing process for impact to the Design History File. Leads and executes activities to close any gaps, such as additional verification testing or updates to risk documentation. Collaborate with Engineering & Production teams to develop and maintain the risk management program for the manufacturing processes. Lead process validation efforts to ensure consistency and reliability in manufacturing outputs. Author process verification/validation protocols and reports. Assessing the need for new gages and equipment. Management of quality inspections as well as equipment calibration, qualification and maintenance. Support internal audits and external audits as needed. Lead efforts to address nonconformities and Supplier Corrective Actions relating to custom-made components. Participate in, or coordinate Corrective/Preventive Actions, investigations and root cause analysis. Additional support for the Quality Management System activities as assigned. On a daily basis, assess overall workload for any area that needs help, and assist coworkers and provide backup as needed without being reassigned by management.

Requirements

• Strong understanding of quality management systems and regulatory requirements in medical device manufacturing- (ISO 13485:2016, FDA 21 CFR 820).
• Experience with process validation, statistical process control, and measurement system analysis.
• Proficiency in quality tools and methodologies (e.g., Kaizen events, Lean Manufacturing, FMEA).
• Strong understanding of metro

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Company Intel

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