Senior Quality Risk Analyst

Overview

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.  We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary:

The Senior Quality Risk Analyst is responsible for determining, communicating and documenting business and patient risk in accordance with international regulations, guidelines and our corporate procedures. They will establish and maintain an operational risk program and related platform and polices, and maintain centralized risk oversight of quality processes. The candidate will work closely and collaboratively with members of the Quality Complaints, Customer Service, Medical Information, R&D, Engineering, Legal and related teams.

Responsibilities

Key Accountabilities

Essential Functions:

• Lead the RAW process:
  • Plan, perform, analyze, and report on risk and impact to add value and im-prove the companies risk control environment for post market activities utiliz-ing an ISO 14971 framework.
  • Responsible for the RAW meetings and follow up activities to ensure team members provide necessary input.
  • Document evidence thoroughly and appropriately, including recommendations for potential CAPA, field action or regulatory filings.
• Interpret requirements of risk documentation for cross-functional team to negotiate a score that is representative of the issue and compliant with internal procedures and external regulations/standards/guidance.
• Aggregate data from multiple internal and external sources to provide a comprehensive assessment.
• Create reports, summaries, presentations, and process documents to display results.
• Identify quality and compliance trends that may present a risk to the company and escalate to key stakeholders as needed.
• The Senior Analyst must have the ability to work on multiple activities simultaneously and be able to work effectively across levels, functions, and locations with a key focus on quality risk management and patient safety.
• Ensuring the risk management and controls framework is adequate.
• Participate in the creation of risk documentation for new products such that it can be used in the post-market setting to make appropriate regulatory decisions for related complaints.
• Ensures application of sound statistical methods and quality tools in the evaluation and documentation of results related to post-market product risk.
• Mentors and consults with other functions regarding application of risk principles.
• Other duties as assigned.

Qualifications

Minimum Knowledge & Experience Required for the Position:

• Minimum of a bachelor’s degree in statistics, engineering, mathematics, or similar. MBA or advanced degree a plus.
• A minimum of 10 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory or comparable experience.
• Thorough understanding of FDA, MDSAP, ISO 14971 requirements for medical de-vices.
• In depth knowledge of quality management techniques (Lean, Six Sigma) and statis-tical techniques required to measure and confirm significant changes.
• Experience working with data to perform analyses and risk assessments to assist in decision making.
• Experience making business recommendations and influencing stakeholders.

Skills & Capabilities:

• Working knowledge of risk management components (e.g., policy/procedures, gov-ernance, reporting, risk control self-assessments) in a regulated environment.
• Strong written, oral, and interpersonal communication skills with a proven ability to communicate and influence effectively at all levels of the organization.
• Strong analytical, documentation, project management, and organization skills, in-cluding attention to detail.
• Must be self-motivated, willing to take on initiative, capable of working inde-pendently, and manage through ambiguity to produce results.
• Proven ability to identify and assess business risks and controls, perform root cause analysis, and work with business partners to develop practical recommendations for optimizing risks.
• Demonstrated ability to prioritize tasks and meet daily deadlines for projects.
• Critical thinking skills with the ability to independently solve problems with data.
• Assist in continuous improvement of the risk assessment process and framework.

Travel Requirements:

• Domestic travel exptected to be less than 10%.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

www.werfen.com