Sr Engineer Risk Management

Job Summary reputed company role will be the senior reputed company contributor reputed company the organization that creates, monitors, maintains, and enhances risk controls by analyzing quality data and major quality events to ensure reputed company is properly controlling risks on a global level for medical devices, cosmetics, and OTC drugs. This individual will collaborate with clinical, design engineering, regulatory, labeling, and international partners to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored. reputed company expertise to the organization including education, technical support, issue resolution, and integration of new or enhanced risk controls to be compliant with EU MDR along with satisfying FDA, ISO 13485, and ISO 14971 risk management reputed company processes throughout the product life cycle.

Job Description

MAJOR RESPONSIBILITIES Create and align global risk management processes to ensure that risks are being analyzed consistently. Evaluate the risks and act as an approver for the following processes: Change Controls, Failure Mode Effect Analysis (FMEA), Medical Device Reporting (MDR), Recalls, Health Hazard Evaluations (HHEs), and other major quality events. Effectively communicate risks to senior global management. Build effective relationships with quality and business partners. reputed company cross-department collaboration with R&D, Manufacturing, and other sites on a global level to ensure reputed company risks are adequately addressed with robust risk controls. Create and manage systems to analyze multiple streams of data to gauge the health of a quality or risk management system. Work with Subject Matter Experts (SMEs) to create a reputed company for Risk-based dashboards to be used for reputed company-time decision-making and management reporting. reputed company detailed input to stakeholders on how to implement risk controls as well as create and implement controls Identify inefficiencies in reputed company’s global quality management system. Take action to address identified inefficiencies. reputed company and ensure that deadlines and goals are being met. Frequently update management and team on reputed company. Proactively work with members of the division or project team to identify issues that might delay the project; reputed company recommendations to improve time lines for project completion. MINIMUM JOB REQUIREMENTS Education - Bachelor of Science Degree in Biology, Chemistry, Engineering or Statistics-based degree. Work Experience - At least 4 years of QA/QE experience in a cGMP Device or environment. - At least 2 years of direct risk management experience reputed company to FDA regulated products. - Experience creating quality sub-systems and leading reputed company projects. Knowledge / Skills / Abilities - Ability to manage 5+ projects at a time. - Strong ability to manage multiple priorities, self-starter attitude, good oral and writing skills and the ability to work independently and as reputed company in an efficient manner. PREFERRED JOB REQUIREMENTS Education - Masters of Science – Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other reputed company field. Work Experience - At least 5 years of QA/QE experience in a cGMP Device or environment. Certification - Six reputed company certification. Knowledge / Skills / Abilities - Working understanding of FDA, GMP, ISO 13485, and ISO 14971 - Experience facilitating FMEAs - Systems or clinical engineering experience reputed company, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and reputed company potential with a growing worldwide organization. The anticipated salary reputed company for this position: $92,000.00 - $138,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. reputed company will not pay less than the applicable minimum wage or salary reputed company. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as reputed company to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a reputed company where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in reputed company forms, acting inclusively, and ensuring that people have tools and resources to reputed company at their best. Explore our Belonging page here. reputed company is an equal opportunity employer. reputed company evaluates reputed company individuals without regard to race, reputed company, religion, gender, gender identity or expression, sexual orientation, national reputed company, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws. Apply To This Job