Global Quality Engineer: CAPA, Audits & Compliance

Dentsply Sirona; Mölndals kommun; On-site; SEK 520,000 - 700,000; Full time

Job summary

Dentsply Sirona Sweden is seeking a Quality Engineer to join our global team in Mölndal. The role focuses on securing Quality Assurance for CAPA and non-conformities, and working closely with sites across Dentsply Sirona to ensure robust quality processes.

You will manage CAPA/NC processes, investigate root causes, review procedures during external audits, support document control, and collaborate with multiple functions to uphold ISO 13485 and MDR requirements.

Qualifications

• Degree in engineering or equivalent professional background.
• Experience in the medical device industry.
• Knowledge of ISO 13485, 21 CFR Part 820 and EU MDR 2017/745.
• Excellent communication with cross-functional teams.
• Experience participating in external audits.
• Proficient English and Swedish communication.

Responsibilities

• Manage CAPA and NC processes for the Mölndal site.
• Facilitate root cause investigations for CAPA/NC.
• Perform QA review of procedures during external audits and follow-up.
• Document Control; provide knowledge and support to the organization.
• Collaborate with global sites to ensure quality system compliance.

Skills

Communication skills

English proficiency

Swedish proficiency

Audits experience

Education

Academic degree in engineering or equivalent

Regulatory knowledge ISO 13485/21 CFR 820/EU MDR 2017/745

Job description

Dentsply Sirona Sweden is seeking a Quality Engineer to join our global team in Mölndal. The role focuses on securing Quality Assurance for CAPA and non-conformities, and working closely with sites across Dentsply Sirona to ensure robust quality processes.

You will manage CAPA/NC processes, investigate root causes, review procedures during external audits, support document control, and collaborate with multiple functions to uphold ISO 13485 and MDR requirements.