Quality Engineer

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 is the world's largest manufacturer of professional dental products and technologies, with over a century of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands.

Dentsply Sirona's products provide innovative, high-quality, and effective solutions to advance patient care and deliver better and safer dental care. Dentsply Sirona's headquarter is located in Charlotte, North Carolina. The company's shares are listed in the United States on NASDAQ under the symbol XRAY. Visit www.dentsplysirona.com for more information about Dentsply Sirona and its products.

We are looking for a Quality Engineer you will work in a Global Environment and be part of a cross functional team.

The main objective for the position is to secure Quality Assurance for critical quality system processes such as CAPA and Non Conformities. You will work in close collaboration with other sites in the DentsplySirona organization.

Responsibilities

• Manage CAPA and NC process for site Mölndal
• Facilitate root cause investigations for CAPA and NC Process.
• Perform QA review of procedures in the
• External Audits, be part of preparation, execution and follow up.
• Document Control, provide knowledge and support to the organization.

Background / Qualifications

• An academic degree in engineering or equivalent professional background and preferably 5 year's experience from the medical device industry.
• Experience from working in the medical device industry and have knowledge about ISO 13485, 21 CFR Part 820 and EU Medical Device Regulation 2017/745
• Excellent communication skills as the role requires close contact with several functions/sites
• Participation in and experience of Audits from external parties
• Good communication in English as well as Swedish, both written and verbally.

We look for a colleague with analytical skills, attention to details and the ability to work both in cross functional team and independently. We believe that you are a positive and social person with the ability to maintain a good relationship with local and global stakeholders. It is an advantage if you have strong focus on and drive to achieve goals and targets.

Equal Opportunity Employer:

Dentsply Sirona is an Equal Opportunity Employer. All qualified applicants will be considered without unlawful discrimination or regard for race, color, religion, sex, sexual orientation, sexual or gender identity, national or ethnic origin, age, marital status, disability, genetic factors, military and veteran status, or any other characteristics protected by applicable local law.

Eligibility:

All successful applicants must be eligible to work in the country the position is based.

Assistance:

If you need assistance with completing the online application due to a disability, please send an accommodation request to [e-mail].

Agencies:

Please note that Dentsply Sirona does not accept or respond to unsolicited requests or applications submitted by Recruitment Agencies/ Search Firms.