Job Description, Responsibilities & Requirements
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.
Responsibilities
- 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
Requirements
- 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 Offer
- Competitive salary
- Opportunity to work in a leading global provider of innovative medical devices
- Professional growth within the medical device industry
About the Company
Wellspect Healthcare is a leading global provider of innovative medical devices that help people suffering from urinary retention or chronic constipation. More than 1,000 employees around the world are dedicated to making a difference to people who need our products and services. Wellspect is one of the worlds’ leading manufacturers of intermittent urinary catheters, with LoFric® as the most known brand. As a help to those with chronic or severe constipation Wellspect has developed what likely is the world’s most advanced irrigation system, Navina™, combining a high degree of user convenience, clinical effectiveness and connectivity into one smart system. Wellspect strives to become climate neutral and leave the smallest possible environmental footprint.
The company, with headquarters in Mölndal, Sweden, is present in more than 30 countries, and part of Dentsply Sirona, the worlds´ largest manufacturer of professional dental technologies. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. Visit www.wellspect.com and www.dentsplysirona.com for more information.
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 [email protected].
Notice on Fraudulent Job Offers
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: careers.dentsplysirona.com.
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