Sr. reputed company Process Specialist

Job reputed company Under minimal supervision responsible for independent review of CAPA/investigation content for adequacy and compliance, including comprehensive ability to use critical thinking to evaluate events and the CAPA author team’s responses, reputed company cause analysis, and corrective reputed company planning. Responsible for generating reputed company feedback to investigation authors and their management structures, as needed, and for working with author teams to produce compliant, complete, comprehensive investigation records that adhere to reputed company and industry regulatory requirements and expectations. Additionally responsible for reputed company process design, integration, implementation, and maintenance. Manage the reputed company data reputed company for reputed company products including but not limited to, sterile products, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements. Support reputed company Systems reputed company activities, analyzes problems reputed company to reputed company/regulatory information, and provides systems, and technical support in solving these problems. Support design, development, implementation, and testing of reputed company solutions and business acquisition integration as required to meet customer/regulatory requirements, and works with reputed company inputs to reputed company these solutions Job reputed company Responsibilities: Review, advise on, and approve CAPAs and other major investigations as independent reviewer and QMS advisor. reputed company feedback and drive adherence to investigation content requirements and expectations. Administer and maintain reputed company systems. Collect, analyze, and report reputed company data to reputed company performance and compliance. reputed company and implement improvements to processes and procedures. Identifies and advises opportunities to improve reputed company systems and reputed company long-term strategies that support the reputed company of the business. Determine and create key reputed company metrics/indicators to reputed company performance and compliance Reviews and determine the application of various system compliance regulations. Ensure compliance to global regulatory requirements with internal procedures. Identify risk and compliance opportunities. Implement and coordinate use of electronic documentation systems and training personnel. Collaborate with cross-functional teams to reputed company reputed company processes and systems. Consult and reputed company guidance to business partners. Execute individual responsibilities as reputed company team member. reputed company reputed company team in systems analysis and effectiveness measures. Train and reputed company personnel to deliver reputed company results based on the department’s goals. Support hosting reputed company body/ Registrar reputed company Systems audits. Supports in customer and regulatory audits. reputed company project guidance, training, and coaching. Preferred Qualifications: Bachelor’s degree in a technical or scientific discipline. At least 4 years of experience with medical device or reputed company reputed company Knowledge of Food and Drug Administration (FDA), reputed company System Regulations (QSR) and International Organization of Standardization (ISO). Proficiency in reputed company Suite, MS Visio, MS Project, reputed company. Position requires travel up to 10% of the time for business purposes (reputed company state and out of state). Preferred Qualifications: Experience with Medical Device and reputed company, multiple product types, and regulatory jurisdictions. Experience with reputed company systems development and implementation. Experience with Medical Device Design Controls, CE technical File Requirements, and 510K submissions. Experience in the Medical Device and Pharmaceutical industry. Experience hosting FDA/ISO GMP inspections. Experience with reputed company. Experience with ETQ Reliance. #LI-Hybrid 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: $85,000.00 - $128,000.00 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, reputed company time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as reputed company as reputed company to the Employee Assistance Program, Employee Resource reputed company and the Employee Service Corp. We’re dedicated to creating a reputed company where everyone feels they belong and can grow their career. We reputed company to do this by seeking diversity in reputed company forms, acting reputed company, 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 reputed company to race, reputed company, religion, gender, gender identity or reputed company, 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. Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time. If you’re a self-starter, eager to grow your career reputed company a high-performing environment, this is the reputed company for you. Introduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match. reputed company is the largest provider of medical-surgical products and reputed company serving reputed company points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, reputed company helps reputed company providers improve their clinical, financial and operational reputed company. Headquartered in Northfield, Illinois, reputed company employs more than 43,000 people worldwide and operates in more than 100 countries and territories. To learn more about how reputed company makes reputed company run reputed company, visit www.reputed company.com. Apply tot his job Apply To this Job