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Quality Assurance Specialist

As Quality Assurance Specialist, you will work with the full scope of manufacturing related QA task, running from batch recorded review and release, deviation and CAPA management and collaborating with our contact manufacturers (CMO´s) to ensure proper implementation of our procedures and corrective actions. You will work closely with and support the CMO production. This position is designed for an individual who thrives in a dynamic environment and is passionate about working closely with production teams to enhance processes, facilitate batch releases, and manage deviations and CAPA to ensure compliance and continuous improvement within the QA field.

Key Responsibilites

Your responsibilities will include, but not be limited to:

  • Review batch records and release batches.
  • Lead and collaborate with Supply Chain, Sales and CMO´s to investigate deviations to ensure resolution of deviations from established processes, collaborating with production to implement corrective actions promptly.
  • Lead CAPA and complaints investigation and manage and facilitate the implementation of Corrective and Preventive Actions (CAPA) in collaboration with the CMO and internal stakeholders.
  • Conduct root cause analyses for issues identified during manufacturing and contribute to the development of effective CAPA plans.
  • Support the QA manager in development of the QMS and QA related processes.
  • Manage and investigate external product related complaints.

Great Place to Work

  • Flexible work model

  • Work globally, hired locally

  • Global environment

  • Fast growing trajectory

  • Career opportunities

  • Fast paced & entrepreneurial culture

Skills & Requirements

Qualifications

  • Bachelor's degree in a relevant field (e.g., Engineering, Quality Assurance).
  • Around 3 years of experience in quality assurance within production in the medical device (class III or IIb) or pharmaceutical industry.
  • Strong understanding of batch release processes, deviation management, and CAPA implementation.
  • In-depth knowledge of relevant regulatory and medical devices standards.
  • Knowledge and experience in MDR and ISO 13485. Knowledge on FDA regulations is preferred.
  • In-depth knowledge of relevant regulatory standards, including ISO 13485 and FDA regulations is preferred.
  • Excellent written and oral communication skills in English. Proficiency in Swedish is desirable, but not essential.

Personality

  • Detail-oriented and organized: Your work is highly organized and precise, with a keen attention to detail and a structured approach to every task to ensure compliance.
  • Resilient and adaptable: You bring a resilient, can-do attitude and demonstrate persistence when facing challenges.
  • Collaborative: You have strong interpersonal and communication skills to effectively collaborate with internal teams and external stakeholders.

Other information

This role can be based remotely, or at our office in central Stockholm. Regular travel to our CMO´s in Uppsala and Malmö will be needed.

Work with great people

Margarida Lencastre
Social Media and Content Specialist
"I joined Nordberg Medical in March 2022, valuing its agile, supportive environment and its mission to enhance lives through science. Here, I see great potential for professional growth."
Tiantong Zhao
Business Support Manager
"I'm honored to grow with Nordberg, enhancing my skills and achieving team successes. I believe we can elevate Nordberg to new heights together!"
Esperanza Casas
Marketing Director
"I joined Norberg Medical in May 2023, drawn by its mission and vision. I'm growing personally, supported by a great team, in a dynamic environment that boosts my creativity and skills."
David Tepper
Finance Director
"I enjoy working with pleasant, humble, and smart colleagues in a positive and energetic environment. The company's exciting, ambitious plans promise an incredible journey I want to be part of."

About the company

Nordberg Medical is a Swedish biotech company working at the forefront of biomaterial science to reverse functionality loss. With state-of-the-art biomaterials, we produce and market innovative medical products that target structural imbalances associated with aging.

In 2021, we passed a critical milestone by receiving CE certification for our first product. JULÄINE™ of Sweden is a biostimulator that activates natural collagen production in the skin. This positions the company well to pursue an ambitious growth strategy in the aesthetic dermatology market.

Backed by leading investors and extensive R&D, we are expanding across multiple therapeutic areas and geographies.

Join an international team of highly talented individuals where your contribution counts. We promote a culture of entrepreneurship, multiculturalism, and flexibility in more than ten countries. At Nordberg Medical, you will have the opportunity to grow and learn, to be creative, and to contribute to both our product and company success.

Add the title below:Our values

EXCELLENCEAt Nordberg Medical we understand excellence as an unwavering commitment to providing the market with outstanding products and services with the overall goal to build long-term partnerships with our medical community and patients.

AUTHENTICITYWe believe that the best way to offer excellent products and services and to build valuable relationships is by authenticity. At Nordberg Medical we understand authenticity by carrying our work ethically, and by communicating with our medical community and patients directly and with honesty.

TRUSTTo achieve excellence and authenticity we strive to inspire trust in our relationships with all stakeholders by nurture. Nordberg Medical is a first-class partner committed to supporting our stakeholders to achieve excellence.

Emelie Wedin | Contact Person

I'm interested
Nordberg Medical

Multiple locations | Remote
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