Site Quality Manager

Why Join Us?

We’re on a mission to empower people with disabilities to do what they once did or never thought possible. As the world-leader in assistive communication solutions, we empower our customers to express themselves, connect with the world, and live richer lives.  
 

At Tobii Dynavox, you can grow your career within a dynamic, global company that has a clear, impactful purpose - with the flexibility to also do what truly matters to you outside of work. What’s more, you’ll be part of a work culture where collaboration is the norm and individuality is welcomed. 

As a member of our team, you’ll have the power to make it happen. You’ll solve challenges, deliver solutions and develop new, efficient processes that make a direct impact on our customers’ lives. 

What You'Ll Do:

To lead and coordinate quality and compliance in the operational unit, focusing on site-specific execution. Ensure that all products manufactured, repaired, and distributed at the site comply with applicable regulatory requirements and company quality standards. Support a culture of quality, continuous improvement, and operational excellence.

As a Site Quality Manager, you will be responsible for:

• Ensure that the site Quality Management System (QMS) is consistently applied and aligns with global standards.
• Oversee compliance and overall quality performance at the site.
• Collaborate with Site Operational Managers to develop, assess, and report on quality KPIs.
• Facilitate quality review meetings and analyze trends to drive continuous improvement.
• Integrate risk management into operations by conducting risk assessments and utilizing pFMEA outputs to guide the quality strategy.
• Investigate product complaints and adverse events to ensure regulatory compliance and product safety.
• Track CAPA (Corrective and Preventive Action) effectiveness and collaborate with production to mitigate quality risks.
• Work with production teams to enhance understanding and application of quality standards and promote proactive quality practices.
• Guide and train production teams and mentor junior quality engineers and staff to strengthen the site's quality culture.
• Collaborating with Product Development (P&D) and Global Quality Teams for New Product Introductions (NPI).
• Support seamless transitions from development to production, providing feedback and implementation assistance.
• Lead validation activities for manufacturing and repair processes, equipment, and product changes to ensure compliance with regulatory standards.
• Responsible for MP validation and testing of MP units (manufacturing process validation).
• Act as a site auditor after completing training, participating in internal audits and supporting audit readiness.
• Manage process change requests and change control processes for the site.
• Drive site-specific quality projects and support global quality compliance initiatives.
• Lead and coordinate continuous improvement and innovation efforts across quality functions.
• Harmonize local site quality processes with global standards while adapting to regional or operational needs.
• Drive and oversee the site self-assessment process to prepare for audits.
• Responsible for ensuring successful site compliance during regulatory or notified body inspections.
• Act as the site's Management Representative, ensuring the QMS is maintained, and top management is informed of performance and improvement needs.
• Ensure alignment with corporate QMS processes and participate in multisite coordination efforts, including document control and cross-site audits.
• Oversee site-level document control, ensuring that procedures, work instructions, and records are up to date, approved, and controlled in compliance with ISO 13485.
• Coordinate with global Supplier Quality Assurance to manage local supplier quality performance and incoming inspection effectiveness.
• Support post-market surveillance activities by collecting and analyzing site-level data related to complaints, returns, and adverse events.
• Ensure quality-related training programs are implemented, completed, and documented for all site personnel in accordance with role requirements.
• Ensure data integrity is maintained across quality systems and support validation of software tools used for quality operations at the site.

Minimum Qualifications:

• Bachelor's or master’s degree in engineering, Life Sciences, or a related technical discipline.
• 5+ years of experience in quality assurance/control roles, with at least 2 years in a leadership or managerial position.
•  In-depth knowledge of ISO 13485, MDR, FDA QSR (21 CFR Part 820), and ISO 14971.
• Strong leadership and team management capabilities.
• Experience with ERP (e.g., D365FO), QMS, and CAPA systems.
• Excellent analytical, communication, and problem-solving skills.

Apply Today!

We believe in empowering individuals - including our own employees - to reach their full potential. So, if you want to change lives while growing your own career, we’d love to hear from you.