Quality Assurance (QA) Manager to Nordberg Medical AB

Nordberg Medical is looking to recruit a Quality Assurance (QA) Manager to join the company.

Nordberg Medical AB is a Swedish MedTech company based in Karolinska Science Park, Stockholm. The company is committed to the development, manufacturing, and marketing & sales of high-end medical devices that focus on cutting-edge bio-materials. Nordberg Medical AB is a daughter company of Changchun SinoBiom Co., Ltd., which has outstanding capabilities in R&D, production, as well as marketing and sales of bio-materials based medical products, and has top-tier Chinese VC/PE investments backed.

Nordberg Medical AB achieved a great milestone: it has received the CE mark of a cosmetic filler (ploy-L-lactic acid, PLLA). This brings the company with enormous business potential not only in European countries, but also in many other countries around the world. Market launch in Europe is planned in October 2021. Nordberg Medical AB is also planning to start the FDA application during the fall 2021.

As a QA Manager, you will be responsible in ensuring that the manufacturing and distribution of Nordberg products are performed in compliance with according to European Medical Device regulations. This function maintains quality compliance with ISO 13485 and Nordberg´s Standard Operating Procedures (SOPs). The quality function also ensures the timely release of incoming product batches into the marketplace for sale; assisting Nordberg in meeting financial sales targets and ensuring that quality product is available to end users.

The position is full-time and based in Stockholm. We evaluate applications continously and welcome your application today!

JOB DESCRIPTION

This QA-role is a newly created position at the company with unique opportunities of growth, value creation and impact. You will be an important part of managing and launching Nordberg’s first CE marked product, which is a more modern formulation and product compared with existing competitors.

Key responsibilities include:

The Quality Assurance role will take a wide range of responsibilities including but not limited to: production (or CMO) establishment and development, validations, batch management, maintenance of quality agreements, review of analytical reports and product release for sale, product inspection (audits) and preparation and development of Standard Operating Procedures. This role is also responsible for document management, archiving of QA/QC records in compliance with ISO 13485 standard.

Quality Assurance tasks include:

• Maintain Nordberg product list
• Assist Regulatory projects that involve QA oversight including stability changes, updates to labelling etc.
• Coordinating new launch shipments
• Manage and evaluate product complaints, deviations, Corrective Actions and Preventative Actions (CAPAs)
• Develop, review, revise and implement SOPs as required
• Annual product reviews and review of stability reports
• Manage maintenance of quality agreements with manufacturers, suppliers, wholesalers and distributors
• Conduct inspections of distributors and key suppliers, wholesalers as necessary as per ISO 13485 requirements
• Implement recall procedures if necessary and perform recall yearly to ensure our recall procedures are adequate.
• Monitor QA aspects of warehousing and shipping practices for compliance with warehouse procedure manuals.
• Liaise with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations.

Quality Control tasks include:

• Timely approval of incoming batches, batch inspection and perform release according to Nordberg´s SOPs
• Maintain appropriate documentation and ensure document compliance according to ISO 13485.
• Manage deviation reports.
• Manage returns
• Manage/check/follow-up on the monitoring the distribution and product handling of physician samples for compliance with labeled storage conditions
• Maintain QC master documents
• Ensure compliance with appropriate SOP’s, policies and guidelines.
• Complete mandatory training in assigned timelines upon hire as well as when new policies, SOP's, guidances are issued.
• Participate in personal development and training sessions as required for the position.

QUALIFICATIONS

Key qualifications for this position include:

• B.Sc. or higher academic degree in Science, e.g. in analytical chemistry
• Background in manufacturing (pharma manufacturing is a plus) and analytical techniques
• 3 + years relevant experience in the regulated pharmaceutical/medtech industry, specifically including Quality Assurance/Quality Control and/or Regulatory Affairs
• Experience with GMP/European Notify Body inspections and third party audits
• Excellent communication skills
• Solid computer skills (MS Office, MS Word, Lotus Notes, excel etc.)

We are looking for someone who is organized, detail-oriented and has solid decision-making and problem-solving skills. You enjoy building relationships and collaboration with people, both internal and external stakeholders, and have great communication skills. Importantly, we believe you to be a dependable and trustworthy person with a strategic mind-set and a can-do attitude. As we are a small company, it is important that you value team-work and supportive athmosphere at work.

If you are ready to bring your QA-experience to this position, we are ready to offer you an exciting opportunity at Nordberg Medical AB!