Quality Assurance Engineer III

Cerus•Concord, CA

22h•$121,000 - $148,000•Onsite

About The Position

Assuring compliance to regulations and standards for medical devices (Class III combination products) and blood components through the development, implementation and maintenance of quality assurance systems and activities, specializing in compliance of manufacturing and production processes. Support activities related to: Design and Development, Risk Management, Quality Engineering, Supplier Quality Agreements, Quality Inspection Planning, Quality Auditing, Supplier Management, Change Control, Device Software Development Life Cycle (SDLC), IEC 62304 software lifecycle compliance, cybersecurity documentation, traceability, and CAPA.

Requirements

Bachelor’s degree or equivalent in engineering or scientific discipline; electrical, mechanical, biomedical, software, systems, or process engineering.
5 years of quality assurance and quality systems experience supporting manufacturing (experience with Class III medical devices with hardware/software and consumables a plus).
Familiarity with software testing methodologies and defect management.
Ability to support cybersecurity documentation and software lifecycle requirements.
Experience creating and executing test cases, including traceability to requirements.
Thorough knowledge of current medical device manufacturing regulatory requirements and international standards with blood components expertise a plus.
Ability to work effectively with cross-functional teams.
Strong communication skills (encompasses verbal, written, interpersonal, listening).
Attention to detail and accuracy; very observant to audit.
Ability to use quality tools such as FMEA/HA, DOE, Six Sigma, SmartSheet, Veeva.
Flexible; ability to adapt to changing priorities.
Ability to set priorities and effectively manage time to manage multiple activities and deadlines.
Willing to travel domestically and internationally (approximately 10% as needed).

Nice To Haves

Quality certification desired (Six Sigma, CQA, CRE).
Experience with developing and monitoring Key Process Indicators (KPIs) is desirable.
Working knowledge of IEC 62304 software lifecycle requirements, software risk management, requirements traceability, and design control documentation in a regulated environment is preferred.
Experience with defining and monitoring supplier quality agreements is preferred.

Responsibilities

Participate in cross-functional teams to support new and sustaining product development, quality improvement, quality plans, risk management, and cost savings projects.
Provide guidance on the development of verification and validation plans, Software Development Life Cycle (SDLC) software testing, IEC 62304 software lifecycle documentation and compliance activities, cybersecurity documentation, oversee change control, test and sampling methods, sample size determination and acceptance criteria.
Perform risk analysis of production, process, and quality data to identify trends and recommend improvements to reduce and control manufacturing process defects and improve quality.
Perform product release and product quality reviews.
Maintain quality tracking tools and dashboards (e.g., Smartsheet-based RMA, CAPA, supplier action, and field issue tracking) to improve visibility, accountability, and closure timelines.
Participate in developing and implementing methods and procedures for inspecting, testing and evaluating raw materials, components and finished products.
Support risk management review meetings and ensure quality documentation meets risk management.
Create and review regulated documents associated with the design and manufacture of Cerus products such as SOPs, specifications, verification and validation protocols and reports, quality control and reliability plans etc.
Conduct Internal and Supplier Audits to support Cerus quality management.
Support QA Internal and Supplier Audits.
Provide support on CAPA investigations and effectiveness.
Regularly interact with other departments and suppliers regarding quality.
Support software lifecycle activities including requirements traceability, software risk management documentation, IEC 62304 compliance reviews, and maintenance of Design History File (DHF) documentation.
Perform other related duties as assigned.