Site Quality Manager

Why Join Us?

At Tobii Dynavox, we empower people with disabilities to do what they once did or never thought possible. We call this mission Power to Be You. Our assistive communication technology helps our customers express themselves, connect with the world, and pursue independence, whether through everyday activities like ordering food or extraordinary feats like running a company. Working at Tobii Dynavox, you'll become part of a team that spans the globe, with offices in the US, Sweden, France, the UK, China, and beyond.

To learn more about what we make possible, meet some of our customers or take a look at some of our solutions.

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.

At Tobii Dynavox, our mission guides what we do, and our values guide us in how we do it. Across the organization, we are committed to being Collaborative, Considerate, Curious and Courageous. We build a trusting environment where every team member prioritizes our customers with empathy and insight. Bold ideas and learning lead to impactful solutions. Driven by curiosity, we continuously challenge the status quo to create meaningful, customer-focused solutions for our customers.

At Tobii Dynavox, we believe in empowering individuals - including our employees - to reach their full potential. Here's what makes us unique:

• Purpose-Driven Work: Join a company that transforms lives by giving a voice to those with communication challenges. Every day, your work makes a meaningful and concrete impact.
• "Yes, and..." Flexibility: Build a rewarding career AND enjoy time with loved ones. We offer flexible work options so you don't have to choose between personal and professional goals.
• Growth and Development: Whether you're advancing your skills or growing your career, we invest in your future with training, learning opportunities, and internal growth paths.
• Inclusive and Supportive Culture: Work in a collaborative, caring environment where diversity and individuality are valued. You'll feel connected to both your team and our global community.
• A Global Leader with Heart: Be part of an innovative, forward-thinking company that combines experience and cutting-edge solutions with a mission to change lives.