The Sr Supplier Quality Engineer will be a key member of Modular Medical's Quality team, collaborating with other team members and suppliers 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- Qualify new suppliers through capability assessments, quality system audits, and initial sample approval processes
- Conduct on-site supplier quality audits as required
- Issue and manage supplier corrective action requests (SCARs) for incoming material nonconformances: define problem requirements, review root cause submissions, and verify corrective action effectiveness
- Track and analyze supplier quality metrics, assist in development of supplier scorecards
- Support critical supplier development programs: identify capability gaps, create improvement roadmaps, and provide technical coaching
- Manage supplier containment activities during active quality nonconformances - requiring 100% inspection, sorting operations, or temporary supply from alternate sources
- Coordinate with receiving inspection, quality engineering, and production on the disposition of nonconforming incoming material
- Assist in nonconformance and complaint investigations, including notification to supplier of problems and batch record reviews
- Manage and support the supplier notification process for changes, both supplier and company initiated changes
- Maintain a positive working relationship with vendors
- 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 5-8 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 supplier quality
- 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.
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.
- Familiarity with REACH and Rohs
- Root cause analysis experience
- Experience in the diabetes space
- Professional working level Spanish
