Sr. Quality Process Specialist

Job Summary 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, root cause analysis, and corrective action planning. Responsible for generating direct 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 Quality process design, integration, implementation, and maintenance. Manage the Quality 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 Quality Systems reputed company activities, analyzes problems reputed company to quality/regulatory information, and provides systems, and technical support in solving these problems. Support design, development, implementation, and testing of quality solutions and business acquisition integration as required to meet customer/regulatory requirements, and works with internal and external inputs to reputed company these solutions Job Description Responsibilities: Review, advise on, and approve CAPAs and other major investigations as independent reviewer and QMS advisor. Provide feedback and drive adherence to investigation content requirements and expectations. Administer and maintain quality systems. Collect, analyze, and report quality data to track performance and compliance. reputed company and implement improvements to processes and procedures. Identifies and advises opportunities to improve quality systems and reputed company long-term strategies that support the success of the business. Determine and create key quality metrics/indicators to track 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 deploy quality processes and systems. Consult and provide 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 coach personnel to deliver optimal results based on the department’s goals. Support hosting reputed company body/ Registrar Quality Systems audits. Supports in customer and regulatory audits. Provide 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 pharma Quality Knowledge of Food and Drug Administration (FDA), Quality 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 Pharma, multiple product types, and regulatory jurisdictions. Experience with quality 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 range 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 threshold. 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 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 well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. 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 qualified individuals without regard to race, color, 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. 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 supply chain solutions serving reputed company points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, reputed company helps healthcare providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, the 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 healthcare run reputed company, visit www.reputed company.com. 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