Sr. Quality Systems Engineer

quip is seeking a Senior Quality Systems Engineer to own supplier quality, manufacturing quality, and product reliability for our consumer hardware products. This role partners closely with engineering and global manufacturing partners to identify field issues, drive root cause analysis, and improve product performance at scale.

This role is full time on-site Monday-Thursday in our DUMBO, Brooklyn design studio, with Fridays remote.

This range represents anticipated base salary range for this position, in addition to competitive benefits and equity (as applicable). We carefully assess and consider several factors with each candidate, including location, role-related knowledge, experience and skills. Compensation may vary based on these considerations.

• →Supplier Governance (SQE): Audit and oversee our Contract Manufacturers' Quality Management Systems to ensure strict adherence to ISO 13485 and ISO 9001 standards. Own and manage the CAPA and deviation processes to ensure systemic compliance and continuous improvement. Conduct supplier audits and track systemic CM performance.
• →Manufacturing Quality & Validation: Partner with CMs to vet and sign off on Master Validation Plans and IQ/OQ/PQ protocols during product setup. Transition these into production by reviewing and optimizing the CM’s ongoing Quality Control Plans (IQC, IPQC, OQC). Monitor yields and limit samples to ensure the factory consistently builds to spec and never ships defective product.
• →Risk Management: Own the master Risk Management files and high-level FMEA documentation. Participate and sign off in new product development.
• →Design Handoff & Spec Tuning: Work closely with the design team and suppliers during NPI to transfer critical design requirements into assembly and testing fixtures. Review early test data, driving alignment between Engineering and CM’s to establish test thresholds that are sensitive enough to intercept defects, while aligning with the supplier’s true process capability.
• →Reliability & Lifecycle Testing: Own the Reliability testing program. Define Ongoing Reliability Testing (ORT) requirements for factory partners and monitor long-term durability and "wear and tear" trends.
• →Quality Data Reporting & Prioritization: Own the "Single Source of Truth" for quality. Manage the ingestion of CX/RMA data, build reporting dashboards, and provide data-driven direction on where to focus engineering investigations.
• →Hands-on RCA & Teardowns: Collaborate with the engineering team in physical product teardowns and Root Cause Analysis (RCA) of field failures and customer returns.
• →Regulatory Support: Support regulatory-related documentation and process needs, building familiarity with applicable requirements over time.

• 4+ years in Quality Engineering or Quality Systems management 
• 8+ years Experience working in new product development with Asian suppliers and contract manufacturers with a focus on high-volume electronic consumer products
• Strong working knowledge of ISO 13485 and ISO 9001 frameworks, with demonstrated experience auditing medical device or high-compliance consumer electronics Contract Manufacturers.
• Expertise in Data Analysis (Excel, SQL, Python) to visualize quality trends.
• Demonstrated experience leading Root Cause Analysis (RCA) and hands-on failure analysis/product teardowns for electro-mechanical hardware.
• High cavitation injection molding and machining process experience
• Deep knowledge of materials, processes, assembly, electronics, and production methods
• Strong communication skills to present quality risks to executive leadership
• Ability to travel internationally 2-3 times per year to be on-site at suppliers
• Ability to attend evening calls with suppliers 1-2 nights per week
• Bachelor’s (B.S.) or Masters Degree in Mechanical or Biomedical Engineering

• Solidworks CAD experience
• Experience with motors and PCBAs
• Experience with IPX rated products that require defense against moisture ingress