The ‘Case Investigation and Resolution’ department is the Center of Excellence for the resolution of global product complaints. The Senior Scientist (CIR) is responsible for effective and timely resolution of global cases, including complaint investigations, risk assessments, root cause analysis. case documentation, trending analysis and preparing reports, ensuring regulatory compliance and optimal levels of customer satisfaction. Provides guidance and mentoring to other case owners on case handling processes, product technical knowledge and participates in the On-Boarding of new employees. Accountable for regular peer reviews of escalated cases and provides feedback. May represent the department on new product development initiatives and act as a team lead for department initiatives. The ideal candidate has strong technical knowledge, expertise of assay workflow and system functionality, enjoys troubleshooting, and has a problem solving mindset.
- Assumes accountability for the timely case management of individual cases (Inquiries, Complaints, PRI/PSIs) according to regulatory and ISO Quality system requirements and needs of the Country Organizations including creation, acceptance, classification, investigation, complete documentation and resolution of cases.
- Provides guidance and feedback to other case owners on the case handling processes and product technical knowledge.
- Responsible for experimental design of complaint investigations, conducts investigation experiments, and analyzes data, using statistical measures, for determining a potential product performance issue. Provides guidance on experimental design approach to other case owners and may oversee investigation activities performed by others.
- Ensures, by collaboration and interfacing with BA, Stakeholders and global functions, that appropriate technical input and recommendations are communicated to Country Organizations, ensuring that the customer is provided with a resolution or workaround in a timely manner.
- Initiates and monitors complaint CAPAs/NCRs and triggers appropriate preventive actions resulting from complaints.
- Accountable for providing information from cases to update product documentation.
- Accountable for timely communication of quality related product information to Country Organizations.
- Accountable for regular peer review of escalated cases and providing feedback and guidance to other case owners on expected documentation practices.
- Oversees complaint databases to identify and report recurring issues to quality management and product development.
- Conducts root cause analysis of complaint cases requiring corrective action. May represents the CIR on the CAPA team to ensure that corrective measures and deviations meet acceptable quality standards.
- Creates and maintains enhanced interfaces with Country Organizations and regional representatives.
- Supports and may represent the department in audits and inspections by ensuring cases are compliant and conform to established quality processes, standards, and regulations.
- Creates regular complaint reports, including trending, statistical analysis and related, to document on-market product quality and performance. Escalates critical issues to the responsible Life Cycle Team and may propose proactive measures. Provide guidance to other case owners on reporting creation processes.
- Performs case-related trending to understand the scope of an issue.
- Performs regular reviews of case handling and documentation quality, CAPA management and analyzes feedback on customer satisfaction to provide recommendations for optimizing processes to increase quality and efficiency standards with a focus on customer, compliance and continuous improvement.
- May represent the CIR on new product development projects (design control projects). Contribute CIR requirements are fulfilled and communicate project relevant information back to the department. Ensure CIR is prepared and trained to support products at product launch.
- Participate in the on-boarding and mentoring activities of new employees and team members as assigned.
- Acts as team lead for department initiatives / projects.
- May act as a proxy for a Principal role.
- The essential job functions and major contributions listed above are not intended to be an exhaustive list of all responsibilities, duties and skills. Incumbents may be required to perform other duties as assigned.
- Bachelor degree of life science, engineering, or a related field, or an equivalent combination of education and work-related experience.
- Advanced degree in Molecular Biology, Microbiology, Genomics, NextGen Sequencing, Chemistry, Bioinformatics or related sciences preferred.
- 5+ years of work experience in a technical product support role, research and development setting, technical customer support role, product complaint handling or related function.
- Proficient in Technical writing.
- Experience with Molecular Biology (including PCR technology), Next Gen Sequencing applications.
- Knowledge of varied regulatory requirements and quality practices, especially in the area of complaint management (e.g., 21 CFR 820.198, ISO 10002, ISO 9001, ISO 13485).
- Prior experience with product complaint handling.
- Solid problem solving and troubleshooting capabilities.
- Experience working with global cross functional teams.
- Bioinformatics knowledge, including experience with short read NGS data, including standard pipelines (eg. bwa, samtools, GATK, Varscan etc.), variant detection algorithms, variant annotation and QC metrics, experience in a high level scripting language (e.g. Python, R, Perl).
- Knowledge of the diagnostic market.
Knowledge, Skills, and Abilities:
- Strong communication skills in English (written and spoken) are essential; Knowledge of additional languages is a plus.
- Detail and technical orientation, with robust analytical and organization skills, problem solving, troubleshooting capabilities and negotiation attitude.
- Demonstrated analytical, solutions oriented and collaborative approach to problem solving
- Product and project risk management knowledge.
- Knowledge of regulations and IVD standards, Good Manufacturing Practices (GMP).
- Knowledge of new product development processes (product design control).
- Computer literate, knowledge of e-learning and multimedia technologies.
- Genuine empathy, patience, flexibility and ability to skillfully direct contacts to resolve issues in a timely manner.
- Strong customer advocate and business orientation.
- Conflict management knowledge.
- Proven presentation and communication skills.
- Certified in lean and six-sigma quality methodologies and utilize quality tools to help drive continuous improvements.
- Up to 20%