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, Quality Auditing, Change Control, CAPA.

Primary Responsibilities:

• Participates 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, 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.
• Participate in devising and implementing methods and procedures for inspecting, testing and evaluating raw materials, components and finished products.
• Lead risk management review meetings and ensure quality documentation meets risk management requirements.
• 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 systems.
• Oversee the internal and supplier audits program.
• Provide support on CAPA investigations and effectiveness assessments.
• Regularly interacts with other departments and suppliers regarding quality matters.
• Perform other related duties as required.

Qualifications/Requirements/Skills:

• Bachelor's degree or equivalent in an engineering or scientific discipline. Seven (7) years quality assurance and quality systems experience supporting manufacturing (experience with Class III medical devices with hardware/software and consumables a plus).
• Quality certification desired (Six Sigma, CQE, CQA, CRE).
• Experience with developing and monitoring Key Process Indicators (KPIs) is desirable.
• Experience with defining and monitoring supplier quality agreements is desirable.
• Thorough knowledge of current medical device and drug 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 in order to audit properly.
• Ability to use quality tools such as FMEA/HA, DOE, Six Sigma.
• Flexible; ability to adapt to changing priorities.
• 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), ESPP, 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 bay area is $144,000-$162,000 annually.Compensation may vary outside of this range depending on various factors, including a candidate's qualifications, skills, competencies, experience, and location. Base pay is one part of the total package to compensate and recognize employees for their work.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.