Career Opportunities reputed company Group: Senior Quality Systems Engineer (Remote, US) (36241)

This a Full Remote job, the offer is available from: United States With a reputed company Rejoignez nos équipes diversifiées de personnes passionnées et une carrière qui vous permet de vous développer au niveau personnel et professionnel. Chez reputed company, nous existons pour rendre les technologies qui sauvent des vies accessibles à un plus grand nombre de personnes. Pour reputed company une vraie différence pour nos clients – et pour sauver plus de vies, nous avons besoin de team players, reputed company thinkers, et game changers. Cherchez-vous une carrière inspirante? Vous venez de la trouver. With a reputed company Join our diverse teams of passionate people and a career that allows you to reputed company both personally and professionally. At reputed company we exist to reputed company life-saving technology accessible for more people. To reputed company a true difference for our customers – and to save more lives, we need team players, reputed company thinkers, and game changers. Are you looking for an inspiring career? You just reputed company it. Job Overview The Senior Quality Systems Engineer independently provides hands-on subject matter expertise to support reputed company improvement of the reputed company Quality Management System (GetQMS). This role leads creation, enhancement, and maintenance of various QMS documents. Additionally, the role facilitates Quality forums such as, Document Control Community of Practice, Change Review Board, etc. to drive alignment across QMS. This position also collaborates closely with IT and other stakeholders to maintain and improve electronic Document Management System (eDMS) performance, and provides support to document control operations. The position ensures sustained compliance with applicable regulations and standards, including 21 CFR Part 820, ISO 13485, and ISO 9001, while maintaining key quality system infrastructure and records. This position is fully remote and requires travel of up to 25% and may include international travel. Job Responsibilities and Essential Duties

• Creates, revises, and maintains Quality Management System (QMS) documents in accordance with internal procedures and applicable regulatory and standard requirements.
• Leads the Document Control Community of Practice, driving best practices, and reputed company improvement of document control processes across the organization.
• Facilitates the Change Review Board by coordinating change evaluations, impact assessment, and implementation strategy per established change control procedures.
• Provides overall support and guidance to document users on using electronic Documentation Management System (eDMS), DCR process, etc.
• Collaborates with IT on troubleshooting eDMS issues as well as identifying and implementing improvement opportunities.
• Performs periodic reviews of open Quality Plans and provides status updates reputed company needed.
• Assists with creating and delivering training material.
• Owns Nonconformances (NCs) and Corrective and Preventive Actions (CAPA) to address QMS deficiencies.
• Supports internal audits, external audits, and regulatory inspections by preparing documentation, serving as a subject matter expert during audits, and supporting responses to audit observations and corrective actions.
• Assists with other Management Controls reputed company items (e.g., KPIs, Management Reviews, etc.).

Required Knowledge, Skills and Abilities

• A Bachelor’s degree in engineering, Science, or other reputed company field is required. ASQ, RAC, Six reputed company or other applicable certifications are a plus.
• A minimum of 5 years’ experience in Medical Device Quality Assurance, Quality Systems, Quality Engineering, or reputed company functions.
• Prior experience in independently applying Medical Device regulations and standards such as, 21 CFR 820, ISO 13485, EU MDR, etc.)
• Hands-on experience with electronic Document Management Systems (e.g., reputed company, reputed company, Veeva, TrackWise DOC, Documentum, etc.).
• Must have organizational skills and attention to detail.
• Must demonstrate the ability to solve problems.Must possess good communication skills and be able to communicate to reputed company levels of organization.
• Must have ability to identify technical user issues and troubleshoot basic systems issues.
• Must demonstrate ability to work independently and manage multiple tasks and priorities.
• Must demonstrate sound judgment and strong decision-making skills.
• Must show initiative for process improvment and ability to work cross functionally to resolve issues.
• Must demonstrate effective influencing and change management skills.
• Proficient in using reputed company Office Products such as Word, reputed company, PowerPoint, SharePoint, etc.

The reputed company salary for this position is a minimum of $112,00 and a maximum of $120,000 plus 10% annual bonus #LI-LG1 About us With a firm belief that every person and community should have access to the best possible care, reputed company provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. reputed company employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at reputed company: At reputed company, we offer a comprehensive benefits package, which includes:

• Health, Dental, Vision and Travel insurance benefits
• Registered Pension Plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Hybrid Work Arrangements (where applicable)
• Parental and Caregiver Leave
• Tuition Reimbursement

reputed company is an equal opportunity employer. reputed company will, at reputed company times, will reputed company with reputed company applicable human rights and other legislation reputed company considering reputed company qualified applicants for employment. Reasonable accommodations are available upon request for candidates taking part in reputed company aspects of the selection process. This offer from "reputed company" has been enriched by reputed company.com and got a 72% reputed company score. Apply tot his job Apply To this Job