* Simple Staffing is hiring for this position on behalf of Cerus *
This is a hybrid opportunity where you'll collaborate in office at least 2-3 times a week at our Concord, CA office.
Summary & Scope of 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.
Primary 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 required.
Qualifications/Requirements/Skills:
- 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.
- 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 desirable.
- 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.
- 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.
- Ability to set priorities and effectively manage time to manage multiple activities and responsibilities.
- Willing to travel domestically and internationally (approximately 10% as needed).
We understand that our people are essential to our success. This philosophy is revealed in our competitive benefits package, designed to improve employees’ lives both on and off the job.
Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), RSUs
Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement
Compensation: The base salary range for this position in the selected city is $121,000-$148,000 annually. Base pay is one part of the total package to compensate and recognize employees for their work.
Benefits
Health insurance, Paid time off, Dental insurance, 401(k), Vision insurance, Life insurance, 401(k) matching, Retirement plan
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Simple Staffing