Quality Engineer

About the position

We are seeking a detail-oriented and highly motivated Quality Engineer to join our QA/RA team in Mölndal/Gothenburg, Sweden. This position plays a key role in ensuring timely and accurate intake of Customer Complaints, acting as CAPA and Nonconformity Facilitator.

The ideal candidate brings a strong sense of accountability, excellent communication skills, and a desire to grow within the medical device industry.

You will in your daily work be responsible for:

• Perform review of Customer Complaints, assess if it is an Adverse Event


• Facilitate root cause investigations for Complaints, CAPA and NC Process


• When needed, take the lead and coordinate cross-functional meetings when an adverse event has occurred


• Perform review of Customer Complaints sent for closing.


• Perform QA review of CAPA and Nonconformities


• Document Control, provide knowledge and support to the organisation


• Act as Document Control Administrator when needed

Background / Qualifications:

Education:

• Bachelor’s degree in a scientific, technical, or healthcare-related discipline preferred. High School diploma or equivalent required.

Experience:

• 3-5 years of experience in a medical device, pharmaceutical, or other highly regulated role required.


• Experience of working within Medical Device Industry and having knowledge about ISO 13485 and 21 CFR Part 820 is a requirement, is a strong plus.


• Experience with investigative processes and root cause analysis is a strong plus.

Key Skills, Knowledge, and Capabilities:

• Proficient in English; strong written and verbal communication skills required.


• Excellent organizational skills and a high degree of attention to detail are fundamental to success.


• Strong comfort level with computer-based tasks, including working across multiple systems or screens simultaneously.


• Proficiency in standard office software (e.g., Microsoft Office Suite); experience with electronic quality or complaint management systems preferred.


• Able to work both independently and collaboratively in a fast-paced, team-oriented environment.


• Familiarity with regulated environments and an understanding of global regulatory frameworks preferred.

We will evaluate candidates on a frequent basis so please make sure to send us your application as soon as possible.

We look forward to hearing from you!