The Quality Engineer will be a key member of Modular Medical's Quality team, collaborating with other team members to ensure compliance with the Quality System Regulations, ISO 13485, and any additional relevant regulations. The role is responsible for maintaining a strong collaborative partnership across various functions within the organization. The Quality Engineer will act as a Quality representative, enhancing awareness, visibility, and communication regarding all quality initiatives to support departmental, functional, and company-wide quality goals and priorities. Effective communication with all levels of the organization is essential.
Role and 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 U.S. Food and Drug Administration (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.
Qualifications and Education Requirements Required- 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.
- May periodically assist in orienting, training, and/or reviewing the work of peers.
- 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.
