Pharmiva is an innovative and rapidly growing FemTech company, based in Lund, Sweden. To further strengthen the company, Pharmiva is now looking for an experienced and driven Quality Manager to be part of our company.
Your key responsibilities will be following:
- Act as PRRC (Person Responsible for Regulatory Compliance)
- Maintain a QMS in compliance with relevant requirements
- Promote the quality mindset and the QMS throughout the organization
- Perform QC and product release
- Suggest and implement quality related process improvements
- Perform quality review and approval of validation and verification plans, changerequests etc.
- Monitor and analyze quality performance data
- Drive management review meetings
- Participate in supplier evaluations
- Act as Lead Auditor for internal and supplier audits
- Support handling of nonconformities and CAPAs
- Train the organization in quality related topics
- Support other activities/projects as relevant
In your role, you will collaborate closely with R&D, Manufacturing, Marketing and Sales. Other key relationships are external partners, such as consultants and authorities, distributors and external organizations, such as authorities and notified bodies.
You have an education in Life Science or equivalent and at least 5 years of work experience from a similar position, and from working internationally with medical device technology and combination products. You need to be well acquainted with European Medical Device Regulation (MDD/MDR) and relevant ISO standards. You have a very good knowledge in spoken and written in English and good knowledge of MS Office and electronic document management system.
Formal Lead Auditor training/certification would be of advantage.
At Pharmiva we value personal skills as much as professional qualifications, and in this role, personality is crucial for success. You are good at working together with others and can express yourself well both spoken and written. You handle cases independently and you are a performance-driven person who can keep deadlines and deliver at a high pace. You are analytical, careful and aware of the details and quality. Furthermore, you are focused and structured and can quickly get involved in new tasks / questions. You also can review large amounts of information and make relevant priorities.
At Pharmiva you will be working together with skilled, dedicated people who enjoy working in a fast growing and innovative organization.
You will be in our headquarter in Lund, Sweden.
Pharmiva is a Swedish FemTech company that develops new, innovative products in order to improve vaginal health. Our first, patented and CE marked medical device product Vernivia® will be launched soon for treatment of Bacterial Vaginosis. An infection that affects one third of all women in the age of 15-49 year. For more information, visit www.pharmiva.com
If you have any questions regarding this position, you are welcome to contact Karoline Akerjordet, tlf: +46 723 00 1446
Please apply to the position no later than 31th March. Send your formal application letter with CV to firstname.lastname@example.org, Subject: Quality Manager Application – Your name