Arjun P. Email & Phone Number

United States

Wilmington, Massachusetts, United States

As a Quality Assurance Manager for New Product Development, my primary responsibility is to ensure that all products undergoing development adhere to regulatory requirements and industry standards, while also meeting the needs and expectations of our customers. I specialize in developing strategies to shepherd a variety of medical devices and combination products from conception through to commercialization, ensuring quality remains at the forefront of every stage of the process.

Wilmington, Massachusetts

Wilmington, Massachusetts

Wilmington, Massachusetts

• Author Product Quality Plans for new or redesigned products as well as products transferred into manufacturing from a non-design related activity.• Author Master Validation Plans (MVP) to outline the overall strategy to qualify the device in accordance with the quality plan, internal and external requirements. The overall strategy includes establishing IQ, OQ, PQ strategy for all processes used to manufacture the device and component qualification requirements for all components sourced internally and externally.• Author Performance Qualifications (PQ). Review and approve IQ/OQ• Participate in DFMEA and PFMEA• Collaborate with Engineering and Supply Chain to source components for devices. Communicate component qualification requirements to suppliers. Review and approve supplier surveys and maintain ASL• Lead/participate in CAPAs from internal and external audit findings • Provide facility support for Calibration and Preventive Maintenance (PM). Create/review calibration investigation for out of tolerance and damaged gages. Assess the impact on product quality due to Calibration and PM• Active member of the EHS committee

Montevideo, Minnesota

I worked with New Product Development, Manufacturing, and Suppliers to ensure product and supplier quality in accordance with ISO 9001 and ISO 13485. Supported product continuation by assuring the quality of components used in manufacturing and resolve supplier/component quality related issues. Additionally responsible for ensuring integrity of Quality System processes (e.g. CAPA, internal audit, etc.) in order to maintain facility certifications (i.e. ISO). Perform Supplier Qualifications. Performed statistical analysis to analyze trends and conduct root cause analysis. Recommended and implemented corrective actions for processesResponsible for the configuration and implementation of InfinityQS SPC software across the company Developed training material, trained all personnel and provided technical support for issuesImplemented GageTrak Calibration Software to monitor scheduled and unscheduled calibrations, track gage locations, retrieve calibration records, generate work orders, produce calibration certificates, maintain equipment calibration, adjust calibration frequency, and provide thorough reporting for management analysisMonitored and improved product quality by developing sampling plans and assisted in mistake proofing processesSupervised Quality Technicians, Quality Inspectors and Incoming inspectors with issues concerning materials, product and process quality

Montevideo, Minnesota

Masters, Engineering Management

Bachelors, Mechanical Engineering