The QMS Engineer supports the establishment and continuous improvement of a compliant Quality Management System, developing and revising QMS process documents, managing document control, ensuring regulatory compliance, and reporting performance metrics.
Compensation
The base salary range for this role is €[Min]–€[Max]. This role is eligible for [bonus/incentive]
Responsibilities
Develop and revise QMS process documents such as SOPs and quality manuals
Manage document control and electronic document management systems
Ensure compliance with QMS standards and regulations
Collect, compile, and report QMS performance metrics
Participate in internal and external audits and root cause analysis
The QMS Specialist is responsible for supporting the establishment of a compliant and effective Quality Management System (QMS), including document development, root cause analysis, and reporting QMS performance metrics.
Compensation
The base salary range for this role is €[Min]–€[Max].
Responsibilities
Develop and revise QMS process documents such as SOPs and quality manuals
Collaborate with cross-functional teams to resolve quality issues through root cause analysis and corrective actions
Collect and report data on QMS performance metrics
Track non conformance reports
Participate in the planning and organization of internal audits
A mid-level quality engineering role responsible for leading complex quality initiatives, supporting cross-functional quality improvement efforts, and mentoring junior quality staff. Acts as a technical subject matter expert for core QMS processes and drives compliance and systemic improvement.
Compensation
The salary range for this position is $77,680-116,520. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary will be subject to a geographic adjustment (according to a specific city and state), if an authorization is granted to work outside of the location listed in this posting.
Responsibilities
Own/drive cross-functional root cause investigations
manage high-impact CAPAs
oversee problem-solving teams (e.g., 8D, DMAIC, or similar)
Own day-to-day execution, administration and continuous improvement of the QMS to ensure compliance with ISO 9001, AS9100, and ISO 13485
Take ownership of key QMS subsystems (e.g., document control, calibration, audit program, supplier quality)
Requirements
Bachelor’s degree in Engineering, Quality, or technical field
Associates degree with at least 3 years working as a Quality Engineer
Nice to have: Lean or Six Sigma Greenbelt certification
Nice to have: ASQ Certified Quality Engineer (CQE)
Lead and continuously improve the risk management framework while working hands-on with product teams across the entire product lifecycle for medical device solutions.
Locations (3)
Gothenburg, Västra Galand, Sweden
Copenhagen, Hovedst, Denmark
Vallauris, Alpes-Côte dAzur, France
Responsibilities
Own and improve the company's Risk Management process, ensuring it meets applicable medical device regulations and standards.
Act as the subject matter expert for medical device risk management and maintain relevant QMS documentation, procedures, and training materials.
Lead risk management activities throughout the product lifecycle, including hazard identification, risk assessments, benefit-risk evaluations, and risk control measures.
Maintain and review Risk Management Files (RMFs), ensuring documentation is up to date and identified actions are followed through.
Ensure risk management is integrated into product development and other key processes, including change control, CAPA, complaints, and post-market surveillance.
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