The Case Investigation and Resolution (CIR) Department is the Center of Excellence for the resolution of global product complaints. The Scientist (CIR) is responsible for effective and timely resolution of global cases, including complaint investigations, risk assessments, case documentation, trending analysis and preparing reports, ensuring regulatory compliance and optimal levels of customer satisfaction. Also participates in the On-Boarding of new employees by providing product and process training and support. The ideal candidate has strong technical knowledge, expertise of assay workflow and system functionality, enjoys troubleshooting, and has a problem solving mindset.

Responsibilities:

• Accountable for the timely handling of individual cases (Inquiry, Complaint, Potential Reportable and Safety issues) according to ISO Quality System requirements and regulations, and needs of the Country Organizations including creation, acceptance, classification, investigation, complete documentation, on-site trouble-shooting and resolution of cases.

• Responsible for experimental design of complaint investigations, conducts investigation experiments, and analyzes data using statistical measures for determining a potential product performance issue.

• Assumes responsibility to ensure, by collaborating and interfacing with the BA and global functions, appropriate measures from cases are derived, including, but not limited to workarounds, in a timely manner.

• Initiates, monitors and ensures completion of complaint CAPAs and triggers appropriate preventive actions resulting from complaints.

• Provides information from cases in order to update product documentation.

• Assumes responsibility for timely communication of quality related information to the Country Organizations.

• Assumes responsibility for regular peer review of escalated cases.

• Supports initiatives and measures to maintain enhanced interfaces with country organizations and regional representatives.

• Provides audit and inspection support as requested.

• Contributes to the creation of regular reports to document on-market product quality and performance, to escalate critical issues to the responsible Life Cycle Teams and to define pro-active measures.

• Contributes to case-related trending to understand the scope of an issue.

• Supports regular review of quality of case handling, CAPA management and analyzes feedback on customer satisfaction to permanently optimize processes to increase quality and efficiency standards with a focus on customer, compliance and continuous improvement.

• Assumes responsibility to ensure risk assessments for product quality issues are complete

• May be responsible for training and mentoring new employees and other team members.

• The essential job functions and major contributions listed above are not intended to be an exhaustive list of all responsibilities, duties and skills. May be required to perform other duties as assigned to meet the CIR goals and objectives as appropriate.

• Other duties as assigned by management.

Qualifications:

• Bachelor’s degree in Life Science, Engineering, or Related Field

• 2+ years of related work experience in technical product support role, research and development setting, technical customer support role or related function

• Proficient in technical writing

• Problem solving and troubleshooting capabilities

• Root Cause analysis knowledge

• Experience working with global cross functional teams

• Solid communication skills (written and spoken) in English are essential

• Knowledge of additional languages is a plus

• Computer literate, with knowledge of e-learning, multimedia technologies

• Demonstrated analytical, solutions oriented and collaborative approach to problem solving Attention to details, technical orientation with excellent organization skills, solid problem solving, troubleshooting capabilities and negotiation attitude

• Very good presentation and communication skills

• Genuine empathy, patience, flexibility and ability to skillfully direct contacts to resolve issues in a timely manner

• Customer advocate and business orientation

• Knowledge of regulations and IVD standards, Good Manufacturing Practices (GMP)

Preferred Qualifications:

• Background in Molecular Biology, Microbiology, Genomics, NextGen Sequencing, Chemistry, Software and or Systems Engineering or related field

• Experience with Molecular Biology techniques including PCR technology

• 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)

The expected salary range for this position based on the primary location of California is $73,200 - $135,900. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Relocation benefits are not available for this job posting.

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination 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 characteristic protected by law.