Quality Assurance Manager II

The Design Quality Assurance (DQA) Manager leads the day-to-day execution of design control and design assurance activities supporting new product development (NPD) and life cycle management (LCM) across Bio-Rad’s in vitro diagnostic (IVD) portfolio and its non-IVD laboratory products serving the research and bio-pharma segments.

You will be accountable for allocating appropriate design assurance resources across a concurrent portfolio of design control projects, for serving as the decision-maker and escalation path for both routine and business-critical project issues, and for leading the assessment of standards, regulations, and requirements applicable to each product — including FDA requirements, MDSAP, ISO 13485, and the EU IVDR for regulated diagnostics, and the applicable global safety, EMC, and market-access requirements for research and bio-pharma laboratory products.

This is a working manager role. You will be personally involved in design control, risk management, software and cybersecurity, continuous improvements, and product safety and EMC requirements, while developing a team of design quality engineers and representing design assurance to R&D, Regulatory Affairs, Operations, Program Management, other RAQA functional teams and senior leadership.

Portfolio and Resource Management

• Allocate and balance design quality assurance resources across NPD and LCM design control projects; maintain a forward-looking resource model aligned to program stage-gate schedules and business priorities.
• Forecast design assurance demand, identify capacity gaps, and propose staffing, contractor, or prioritization solutions to leadership with supporting rationale.
• Establish and report design assurance metrics to functional and program leadership.

Design Control Execution and Oversight

• Own design assurance deliverables and approvals across the full product life cycle: design and development planning, design inputs, design outputs, design reviews, verification, validation, design transfer, design changes, and Design History File (DHF) completeness and inspection readiness.
• Ensure design control practices and processes satisfy 21 CFR Part 820 (FDA Quality Management System Regulation, QMSR), ISO 13485:2016, ISO 9001, and EU IVDR (Regulation (EU) 2017/746) requirements.
• Provide design assurance sign-off at phase gates; withhold approval where objective evidence does not support the transition, and articulate the compliance and business rationale for that position.
• Provide oversite/input to design change and change-impact assessment, including significant-change evaluation, regulatory notification triggers, and re-verification and re-validation scope decisions.

Escalation and Issue Management

• Serve as the first-line decision-maker for escalations and the accountable owner of critical escalations, including verification and validation failures, nonconforming design outputs, standards-compliance gaps discovered late in development, and conflicts between schedule commitments and compliance obligations.
• Drive escalations to closure with documented, risk-based rationale; prepare and present clear recommendations and options to senior RAQA, R&D, and business-unit leadership.
• Interface with post-market functions on complaint, field action, CAPA, and post-production feedback carrying design implications, ensuring the risk management file and design outputs are updated accordingly.

Standards, Regulations, and Requirements Assessment

• Lead the assessment and applicability determination of standards, regulations, and requirements for the assigned portfolio covering both IVD products (FDA, MDSAP, ISO 13485, IVDR) and non-IVD laboratory products used in research and bio-pharma applications, including Research Use Only and laboratory equipment classifications.
• Maintain standards applicability matrices, gap assessments, and remediation plans; monitor standard and regulation revisions and drive timely impact assessment across existing and in-development products.
• Ensure defensible product classification, alignment of intended-use and labeling claims, and requirements traceability from regulation and standard through design input to verification evidence.

Risk Management

• Govern risk management across the portfolio per ISO 14971:2019, with ISO/TR 24971 guidance: risk management plans and files, hazard and harm analysis, FMEAs, risk control verification, benefit-risk determination, overall residual risk evaluation, and production and…