Quality Assurance Manager II

Bio-Rad Laboratories•Hercules, CA

4d•Onsite

About The Position

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.

Requirements

Bachelor’s degree or equivalent in a scientific or engineering discipline.
8+ years’ relevant quality systems experience with supervisory experience, or equivalent combination of education and experience.
Experience working in the in a medical device, pharmaceutical or other regulated industry.
Thorough knowledge of medical device/drug/biotech manufacturing process and experience with risk management regulations and standards, including FDA 21 CFR 820, MDSAP, IVDR, ISO 13485, ISO 14971, Global EMC and Safety standards (IEC 61010, IEC 61326) and Cybersecurity (IEC 81001).
Direct experience supporting FDA inspections, MDSAP audits, and/or notified body assessments as a design control subject-matter expert.
Communication, public speaking, decision-making under stressful conditions, word processing, and spreadsheet and skills required.
Successful candidates will actively seek interaction with others, under potentially challenging time pressures, in order to resolve difficult technical issues.
Ability to self-prioritize and manage several urgent high profile projects at once while remaining customer oriented and goal focused.

Nice To Haves

Experience working in a global organization and/or interfacing with multiple manufacturing locations a plus.
Quality Engineer, Quality Manager, Six Sigma Green Belt or Black Belt desirable.

Responsibilities

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.
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.
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.
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.
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 post-production information feedback.
Coach project teams on risk-based decision-making, and ensure risk management drives verification and validation strategy rather than documenting it after the fact.
Provide design assurance oversight of software as part of the product and software in a medical device, including IEC 62304 life cycle processes, software risk management, and software verification and validation.
Ensure cybersecurity requirements are engineered in and evidenced, FDA premarket and postmarket cybersecurity guidance, IEC 81001-5-1 and AAMI TIR57 practices, threat modeling, SBOM generation and maintenance, vulnerability management, and secure-by-design controls.
Own design assurance oversight of electrical safety and electromagnetic compatibility compliance for instrumentation, including IEC 61010-1, IEC 61010-2-101 for IVD equipment, other applicable IEC 61010-2 parts, IEC 61326-1 and IEC 61326-2-6 for IVD EMC, and applicable laser (IEC 60825 series), biocompatibility, and shipping and environmental standards.
Coordinate with R&D, RA and test laboratories and notified or certification bodies on compliance test planning, deviations, and certification evidence; ensure results are reflected in the DHF and technical documentation.
Support usability and human factors engineering per IEC 62366-1 and applicable FDA human factors guidance, and labeling and IFU compliance per the ISO 18113 series, ISO 15223-1, and UDI requirements.
Act as the design control subject-matter expert for FDA inspections, MDSAP audits, notified body IVDR assessments, ISO 13485 and if applicable ISO 9001 certification audits, and customer or partner audits; prepare the team and the DHFs for audit readiness.
Own, author, and improve design control and design assurance procedures, templates, work instructions, and training; drive harmonization of design assurance practice across product lines and sites.
Lead or support CAPA and effectiveness checks for design-related findings.
Recruit, coach, develop, and manage the performance of a team of design quality engineers; set objectives, conduct reviews, and build technical depth and bench strength in design control, risk management, and standards compliance.
Build strong working relationships with R&D, Regulatory Affairs, Program Management, Operations, Manufacturing Engineering, Supplier Quality, Service, and Marketing; represent design assurance in cross-functional governance forums.
Support R&D and Supply Quality in the application of design and development outsourcing and supplier controls where development activities are performed externally.