Quality Engineer: Data-Driven Compliance for Medical Devices

Modular Medical, Inc.; San Diego (CA); Hybrid; USD 80,000 - 130,000; Full time

Job summary

Modular Medical, Inc. Quality Engineer position seeks a key member of the Quality team to ensure compliance with the Quality System Regulations, ISO 13485, and related regulations.

The role collaborates across functions to promote quality initiatives and supports audits and CAPA processes. The engineer will develop data analysis for quality metrics, drive reviews, coordinate the management review process, and ensure timely quality deliverables while communicating across all levels of the

Qualifications

• BS degree in engineering, data science, technical or scientific discipline; and/or equivalent combination of education and experience.
• Minimum 3-5 years' experience in the FDA regulated environment, preferably associated with medical devices.
• Work under minimal supervision. Relies on experience and good judgment to plan and accomplish assigned goals.
• Experience with statistical analysis and trending of data
• Experience with quality systems and standards compliance
• Familiarity with FDA/ ISO and IEC standards and regulations
• Excellent verbal and written analytical/problem-solving, communication, negotiation, interpersonal and presentation skills
• Advanced personal computing skills, including report writing, and familiarity with common MS Office applications
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment
• Ability to leverage and/or engage others to accomplish projects.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to maintain regular and predictable attendance

Responsibilities

• Develop data analysis and trending processes for quality metrics, including establishing alert and action limits
• Manages and drives regular review of quality metrics
• Assists in organizing and coordinating the management review process
• Works closely with program teams to ensure timely and accurate completion of Quality deliverables
• Drives quality, reliability, and compliance with standards and regulations
• Conducts nonconformance and complaint investigations, including proper documentation and timely completion
• Acts as the CAPA coordinator
• Responsible for ensuring proper processes and procedures are followed, driving improvements to maintain compliance and enhance efficiency.
• Support both internal & external audits, including front/back room support and audit responses.
• Complies with FDA regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Exercise good judgment in planning and organizing work; monitors performance and reports status.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, when necessary .
• Preferred: Experience with statistical methods (e.g. SPC, sampling plans, gauge R&R, DOE)
• Preferred: Experience setting up software platforms for measuring big data.

Skills

Statistical analysis

Quality systems

FDA/ISO standards

Communication skills

Problem solving

MS Office

Team player

Attention to detail

Time management

Education

Bachelor's degree in engineering/data science/technical

Job description

Modular Medical, Inc. Quality Engineer position seeks a key member of the Quality team to ensure compliance with the Quality System Regulations, ISO 13485, and related regulations.

The role collaborates across functions to promote quality initiatives and supports audits and CAPA processes. The engineer will develop data analysis for quality metrics, drive reviews, coordinate the management review process, and ensure timely quality deliverables while communicating across all levels of the