The Opportunity

We are seeking a Quality Systems Specialist to join our Quality Assurance department. Working under general supervision, this role is heavily involved in the creation, review and approval of Synaptive’s QMS procedures and work instructions. This position is responsible for maintaining an ISO 13485, MDSAP and MDR compliant system. Other direct responsibilities include: analyzing complaints for reportability, continual improvement projects, oversight and maintenance of records, including internal audits and being an advocate for quality across the organization. This is an opportunity to evaluate and manage risks, risk treatment plan, and monitor the implementation of risk mitigations and to evaluate their effectiveness, all of which support the Synaptive Quality Management System.

This role will reside on the Quality System team, which has a mission to provide a compliant and effective Quality Management System (QMS) that helps Synaptive and its employees achieve their collective objectives.

What You’ll Do

• Interact with other departments to develop and maintain a compliant quality system using industry best practices as a foundation
• Identify compliance gaps and develop plans to address those gaps
• Update, develop SOPs and ensure timely implementation of the SOPs in Fusion Electronic System
• Assist in document management activities such as creating and updating procedures, process flow diagrams and work instructions
• Lead and supports Quality System Improvement projects
• Oversee product quality complaint investigations, providing quality input and ensuring regulatory compliance.
• Oversee the review and approval process for Engineering Change Orders (ECOs), and Document Change Orders (DCOs), ensuring that all changes are appropriately managed and aligned with quality standards.
• Partner with HR in the management of the training matrix.
• Responsible for the administrative management and oversight of the Fusion Electronic System
• An active participant in the review of CAPA Tasks, including investigation, RCA, corrective and corrective action
• Responsible for identifying new QMS risks and risks mitigation of identified risks using Process Failure Modes and Effects Analysis
• Assist in the creation of internal audit plans and participate in internal/external QMS audits
• Identify risks and justify acceptable risks across the quality management system
• Update quality monthly KPIs and take appropriate action to address those KPIs with direct responsibility
• Perform routine quality control tasks required in medical device development, manufacturing, and servicing
• Perform other related duties as necessary to meet the ongoing needs of the organization

What You’ll Need

• Bachelor’s degree or equivalent experience
• Minimum 5-year experience working in a medical device regulated industry
• MDSAP ISO 13485:2016 Internal Auditor Training

It’d Be Amazing If You Had

• Experience using software platform, such as Fusion, Trackwise or MasterControl
• Previous Quality Assurance experience in the medical device or similar industry
• Knowledge of 21 CFR 820, ISO13485:2016, MDSAP, MDR and ISO 14971

About You

• Self-motivated and results oriented
• Commitment to work collaboratively with colleagues towards team objectives, in-line with guiding principles
• Enthusiasm towards learning new methodologies of working, which may involve shedding habits
• Communication of intent to support decision-making and team alignment
• Perceptiveness of emotional intelligence, and employment of active listening skills
• Resourcefulness to research topics or investigate issues without instructions
• Cooperation when new strategies, processes, tools, and business/regulatory requirements require adaptation