Sr. Quality Systems Engineer

DESCRIPTION

Base Salary: $135k-$165K

• 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.

RESPONSIBILITIES

• 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.