QA/QC Specialist Suturion
Welcome to Suturion AB, a medical device startup company based in Lund, Medicon Village, founded by Dr. Gabriel Börner in 2018. The company develops devices for the wound closure market. Today, the abdominal fascia is closed by the surgeon working manually with a needle driver and a suture. This is time consuming and unnecessary complications often occurs. As many as 1/3 of the patients will suffer from any type of complications related to the closure of the abdomen. Complications that may occur are incisional hernias, burst abdomen and infections.
With the technology developed by Suturion, the company strives to standardize the closure of the abdominal wall, which will save time and money for both patients and healthcare professionals. Another positive outcome is a reduction in the number of complications, which in many cases lead to a new operation.
Suturion's current product portfolio includes the SutureTOOL, an innovative suture applicator, and an absorbable suture to use with it. There are more products within the surgical area in the pre-study phase.
For more information about Suturion please visit www.suturion.com.
As we prepare for a significant commercial launch in Europe and the US in the coming months, we are seeking a proactive and skilled QA/QC Specialist to join our growing team.
As a QA/QC Specialist, you will play a key role in our quality assurance team. You will work closely with our RA/QA Manager to ensure all our products meet both regulatory and internal quality standards. Your responsibilities will include assisting in quality documentation, conducting product inspections, supporting internal audits, and maintaining supplier quality records.
Main Responsibilities:
- Assist in the preparation, review, and organization of quality documents such as Standard Operating Procedures (SOPs), Technical Files, Device Master Records (DMRs), and batch records
- Conduct quality checks at various stages of production to ensure products meet specified quality requirements
- Assist in the non-conformance management process, participate in root cause analysis and recommend corrective and preventive actions (CAPA)
- Support internal and external audits, including preparing necessary documentation and following up on audit findings
Professional Qualifications:
- A Bachelor’s degree in a relevant field such as Life Sciences or Engineering
- 1-2 years of experience in Quality Assurance, Quality Control, or a similar role within the medical device, pharmaceutical, or other regulated manufacturing industries
- Familiarity with FDA, ISO, and/or GMP regulations is meriting
- Fluent in English, both spoken and written
Personal Skills:
- Excellent organizational skills and the ability to multitask effectively
- Strong attention to detail with a focus on accuracy in data entry and documentation
- The ability to work independently and take initiative
- A collaborative mindset and strong team orientation
- A can-do attitude
- Structured, but yet thrives in the flexibility required by a dynamic startup environment
Why Suturion? We offer a dynamic work environment with opportunities for personal and professional development. Here, you get the chance to contribute to products that make a difference in people's health worldwide.
This is a full-time position starting with a probation period of 6 months. You will be based at our office in Lund, but we offer a hybrid remote solution.
We have collective agreement with Unionen, Tekniktjänsteföretagen, and following benefits are included with the employment:
- Bonus system
- Flexible working hours
- Possibility to work remotely
- Pension plan
- Health care allowance
- 4 days reduction of working hours
Interested? Please submit your resume and cover letter via GDPR-safe link by 31st of October. For more information about the position, contact our Recruitment Consultant Pernilla Agardh at +46 72 249 94 80. We will evaluate applications on an ongoing basis and hire as soon as we find the right candidate. We look forward to hearing from you!