Quality Management System (QMS) Specialist

Job Description

The Quality Management System (QMS) Specialist is part of the dedicated Quality team for the multi-modality factory, Factory Best. The Quality department ensures product quality, while maintaining full compliancy and driving manufacturing excellence to achieve timely releases of products with high quality and outstanding reliability. As a QMS specialist you will work in the QMS team who maintains the QMS, manages internal and external audits and manages CAPA.

Your role:

• Assists the Factory Best organization by managing and taking ownership of local Q&R processes, addressing compliance deficiencies and ensuring local process ownership for all activities under the QMS governance in the assigned areas (Audits, Document Control, Training, CAPA) to ensure that the QMS is efficient and meets the regulatory requirements.
• Contributes to the development, implementation, and revision of QMS processes and quality manuals, ensuring their accuracy, clarity, and compliance with relevant standards. Participates in continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to drive overall quality performance and operational excellence. Check QMS document changes for compliance and effectiveness, e.g. ISO13485.
• Contribute to the availability of metrics/KPI data to measure training effectiveness, PQMS deployment and QMS compliance.
• Prepares for and participates in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provide responses to audit findings in collaboration with stakeholders. Ensure proper audit planning and schedule meets the requirements of internal and external policies and external regulations.
• Support Business Units with regulatory submissions, for new products/solutions, existing products/solutions. Support training and training administration as per the QMS and contribute to training content for local QMS documents as necessary.

You're the right fit if:

• You have a minimum of 3+ years' experience working in Quality/Quality Management Systems and/or regulatory affairs within a highly regulated industry (Medical Device strongly preferred), with a strong understanding of global regulations, requirements, and standards such as 21 CFR Parts 820, ISO 13485 and MDSAP.
• You’re experienced with project implementation as an active contributor on projects with scheduled deliverables/timelines.
• You have strong familiarity with process management methodologies/practices and experience coaching owners of CAPAs and audit findings.
• You have the proven ability to partner with a business and effectively interact with/influence employees, and managers on all levels.
• You are people-oriented, pro-active, have a passion for Quality/continuous improvement and are able to work in a fast-paced environment.
• You have a minimum of a Bachelor’s Degree in Engineering, Quality or related disciplines.

How we work together:

We believe that we are better together than we are apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office role.

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