Quality System Compliance Manager - Medical Device

SharkNinja•Needham, MA

8d•Hybrid

About The Position

As the Quality System Compliance Manager, Medical Devices, you will lead the design, implementation, and continuous improvement of SharkNinja’s Quality Management System (QMS) for medical devices. This role is accountable for ensuring regulatory compliance while deliberately shaping a QMS that works within a high-velocity, consumer electronics product development environment. You will establish a QMS that is integrated, digital-first, and ownership-driven—aligned to SharkNinja’s specification developer model and embedded directly into existing new product development (NPD) processes rather than operating as a parallel or centralized function. The role partners closely with Engineering, PMO, Quality, Regulatory, Legal, and Product teams to ensure quality is operationalized across the organization and supports rapid innovation and scale.

Requirements

Bachelor’s or Master’s degree in Engineering, Life Sciences, Quality, or a related technical discipline.
7–10+ years of experience in medical device quality systems, preferably within consumer electronics, electromechanical devices, or high-velocity product development environments.
Demonstrated experience designing, implementing, and operating QMS compliant with 21 CFR Part 820 / FDA QMSR, ISO 13485, EU MDR, within an MDSAP-aligned audit framework.
Strong hands-on experience with core QMS processes, including document control, CAPA, NCRs, audits, training, supplier quality management, and post-market surveillance.
Deep understanding of design controls and risk management for electromechanical medical devices, including ISO 14971, hazard analysis, DFMEA, and lifecycle risk management.
Strong cross-functional influence, communication, and stakeholder management skills in complex, matrixed organizations.
Pragmatic, systems-thinking mindset with a proven ability to operationalize QMS compliance in fast-paced, innovation-driven environments.

Responsibilities

Own and evolve the global Medical Devices Quality Management System (QMS), ensuring sustained compliance with 21 CFR Part 820 / QMSR, ISO 13485, MDSAP, and EU MDR, while enabling rapid, concurrent product development across multiple programs.
Establish QMS governance, decision rights, and escalation mechanisms to ensure consistent execution across products, programs, and geographies.
Maintain a risk-based, audit-ready QMS supporting development, commercialization, and lifecycle activities across North America, the EU, and MDSAP-participating markets.
Design a QMS aligned to SharkNinja’s consumer electronics NPD model, emphasizing embedded controls, simplified documentation, digital evidence, and distributed ownership rather than centralized quality gatekeeping.
Embed QMS into NPD Processes & Digital Tools: Integrate quality system requirements directly into existing workflows and platforms (e.g., PLM, Veeva, Greenlight Guru, Test Management tools, JIRA, eQMS), ensuring design controls, risk management, change management, and documentation are executed within standard development workflows with minimal manual overhead and clear, audit-ready digital evidence.
Lead and support internal audits, external audits, regulatory inspections, and management reviews, serving as the primary quality systems authority.
Oversee core QMS processes—including document control, NCRs, CAPAs, training, supplier quality management, post-market surveillance, and change management—and foster a quality culture where QMS activities are embedded into day-to-day execution and enable speed, clarity, accountability, and informed risk-taking.