QA Lead – Medical Devices & Packaging Development

SimplyVision GmbH seeks a QA Lead in Basel to oversee medical device and packaging development projects, ensuring quality compliance and leading cross-functional teams.

The company is looking for a QA Lead to provide strategic quality oversight for global GDPD project teams. This role involves representing QA DDS in various global forums, managing project risks, and ensuring that all development activities meet strict quality standards and regulatory requirements.

Responsibilities

• Guide global GDPD project teams and represent QA DDS in sub-teams, quality board meetings, and development gate reviews.
• Provide strong quality guidance and technical expertise to ensure oversight on assigned development projects.
• Develop project strategies, including contingency planning and risk assessments, to meet quality deliverables on time.
• Manage interactions between QA DDS and other internal or external departments to ensure smooth project execution.
• Communicate project strategies, key issues, and critical topics promptly to management, project leaders, and team members.
• Review and approve contracts and QA agreements with third parties, including amendments for specific projects.
• Lead or participate in global and cross-functional initiatives to drive quality improvements.
• Collaborate with GDPD as part of device project teams, acting as the QA approver for technical documentation.
• Assess the impact of changes to medical device design and manufacturing and support related actions.
• Author and maintain QMS documentation, such as SOPs, WPs, FRMs, and ATTs.
• Support teams in preparing for and hosting Notified Body inspections.
• Approve 1QEM records in the Trackwise system, including deviations and OOX records.
• Assess impacts of new regulations and standards on medical devices and track resulting actions.
• Manage project trackers and prepare materials for governance and management forums.

Requirements

• Bachelor’s degree with over 10 years of experience in pharma quality or operations, or a Master’s degree with over 5 years in the same fields.
• Fluent English skills, both oral and written.
• Broad understanding of quality standards and policies in medical device manufacturing and control.
• Experience with Notified Body Inspections.
• Extensive experience in device development, Quality Assurance, and/or Quality Control.
• Proven track record in leading interdisciplinary teams, such as scientists on technical projects, in TRD or equivalent roles.
• Ability to contribute to matrix teams with strategic thinking, quality awareness, and implementation skills.
• Computer literacy, including MS Office and document management systems, with readiness to learn new systems.

Nice to have

• Good oral skills in the local site language.