Senior Quality Systems Engineer

At Modular Medical, our goal is to simplify diabetes management, ensuring that everyone has access to the superior care that insulin pumps offer. We believe that managing diabetes should be empowering, not intimidating. You shouldn’t have to be a tech expert or a math genius to take charge of your health. 

Please note: This is an on-site position is based in San Diego, CA. This role is not eligible for relocation assistance.

The Senior 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 Senior 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
• Ensure timely completion of nonconformances, including proper documentation and investigations
• Acts as the CAPA coordinator and effectively leads CAPA projects through all phases in a timely manner
• 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.
• Support manufacturing process development & qualification for new product commercialization and product changes
• Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
• Assist in the supplier qualification process and supplier audits as required
• 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.

Education: BS degree in engineering, data science, technical or scientific discipline; and/or equivalent combination of education and experience.

Experience:

• Minimum 5-8 years' experience in the FDA regulated environment, preferably associated with medical devices.

Skills (Required):

• 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.

Skills (Preferred):

• Experience with statistical methods (e.g. statistical process control, sampling plans, gauge R&R, and design of experiments)
• Experience setting up and utilizing software platforms designed for measuring big data.
• Experience with supplier controls
• Root cause analysis experience
• ASQ CQE or other professional certifications
• Experience in the diabetes space

Physical: 

• Ability to sit or stand for extended periods of time
• Ability to infrequently lift and/or move up to 35 pounds

Note: Only local applicants with the legal right to live and work in the US will be considered for this position.

Compensation: The pay range for this position is $97,162-$151,611 annually. The actual base pay offered may vary depending on several factors, including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. Additionally, we offer a comprehensive benefits package for our employees and their dependents, including medical, dental, vision, and life insurance, a generous PTO policy, and new hire stock options.

Application Policy: Modular Medical does not accept unsolicited resumes or applications from agencies. Please refrain from forwarding resumes to the Talent Acquisition team or employees. Modular Medical will not be responsible for any fees related to unsolicited resumes.

Equal Opportunity Employer: Modular Medical is an Equal Opportunity Employer. We embrace diversity and are dedicated to fostering an inclusive environment for all employees. We do not discriminate based on race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or any other legally protected characteristics.