Senior Quality Assurance Specialist

Nordberg Medical; Stockholms kommun; Hybrid; SEK 600,000 - 800,000; Full time

Benefits offered by this job

Flexible working schedule

Career development opportunities

Inclusive team environment

Job summary

Nordberg Medical is seeking a Senior Quality Assurance Specialist to ensure compliance with quality and regulatory requirements for its flagship product, JULÄINE, a Class III medical device. The position involves collaboration with cross-functional teams to drive quality documentation submissions and ensure organizational quality standards.

You will be a key member of the global Quality Assurance team, focusing on continuous improvement and maintaining regulatory compliance across various regions. This hybrid or remote role requires legal eligibility to work in Sweden.

Qualifications

• Bachelor’s degree in life sciences, engineering, biomedical engineering, or pharmacy.
• Experience in Quality Assurance within the medical device industry.
• Knowledge of Quality Management Systems requirements, preferably ISO 13485.

Responsibilities

• Support the development and maintenance of the QMS.
• Ensure quality processes are effectively established and monitored.
• Drive the creation and harmonization of quality procedures.
• Oversee change control activities and ensure compliance.
• Coordinate CAPA processes and ensure timely follow-up.
• Prepare quality inputs for management reviews.

Skills

Quality Management Systems

Regulatory compliance

ISO 13485

Analytical skills

Cross-functional collaboration

Education

Bachelor’s degree in life sciences or related field

Job description

As a Senior Quality Assurance Specialist, you will play a key role in ensuring compliance with quality and regulatory requirements for both our current and future product portfolio. Initially, your primary focus will be on our flagship product, JULÄINE, a Class III injectable medical device.

In this role, you will collaborate closely with cross‑functional teams, including the broader Quality Assurance and Regulatory Affairs teams, as well as stakeholders in Manufacturing, Commercial, Clinical Affairs, and Research & Development. Together, you will drive the preparation and submission of quality documentation to meet regulatory standards and support product approvals across multiple regions.

You will report directly to the Senior QA Manager.

About the Team

You will join our global Quality Assurance team, with colleagues based across several European countries. The team plays a critical role in the company’s success, working collaboratively to ensure the highest quality standards. We foster an entrepreneurial and team‑oriented culture, where you will have the opportunity to deepen your expertise, broaden your experience, and contribute to expanding our presence into new markets and product areas.

Key responsibilities

• Support the development, maintenance, and continuous improvement of the QMS in accordance with applicable regulatory requirements and standards (including ISO 13485, MDR, MDSAP).
• Ensure quality processes are effectively established, monitored, and continuously improved across the organization.
• Drive the creation, review, and harmonization of quality procedures, work instructions, and quality documentation.
• Oversee change control activities, ensuring appropriate quality assessment, implementation, and effectiveness verification.
• Support and maintain traceability processes to ensure compliance throughout product lifecycle activities.
• Coordinate CAPA processes and ensure timely investigation, implementation, and effectiveness of corrective and preventive actions.
• Collaborate cross‑functionally with other departments (e.g. Regulatory Affairs, Operations, R&D) to ensure quality objectives are achieved. Support internal and external audits and drive follow‑up actions to close.
• Contribute to inspection readiness and support interactions with certification bodies and regulatory authorities.
• Monitor and analyse QMS performance through quality metrics.
• Prepare, consolidate, and maintain quality inputs to support management review activities, ensuring timely availability of performance and compliance data.
• Generate periodic quality reports and trending analyses to support management decision‑making and continuous improvement initiatives.
• Support the development and delivery of training programmes related to QMS processes and quality requirements across the organization.

Required qualifications

• Bachelor’s degree in life sciences, engineering, biomedical engineering, pharmacy, or related field.
• Previous experience in Quality Assurance within the medical device industry or another regulated environment.
• Knowledge of Quality Management Systems requirements, preferably ISO 13485; experience with equivalent quality standards (e.g. GMP) may also be considered.
• Fluency in English (written and verbal).

Beneficial qualifications

• Experience working under Medical Device regulatory frameworks, including MDR (EU 2017/745), MDSAP and/or FDA Quality System requirements.
• Knowledge of ISO 14971 and risk management principles.
• Previous experience supporting external audits, regulatory inspections, or certification activities.

Personal attributes

• Committed, reliable, and able to maintain focus in a dynamic environment, with a strong sense of ownership and accountability.
• Highly organized, with strong attention to detail and the ability to prioritise effectively, combined with excellent analytical and organisational skills.
• A proactive mindset with a continuous improvement approach, demonstrating a high level of integrity and professionalism in all aspects of work.
• A collaborative attitude, with the ability to build effective cross‑functional relationships, and consistently demonstrating enthusiasm, engagement, and pride in delivering high‑quality work.

Other information

This role can be based at any of our European locations and offers a flexible hybrid or remote working setup. You will be expected to travel and attend group meetings on a regular basis.

Please note that you must have the legal right to live and work in the country where you are based, as employment eligibility requirements may vary by location, and we are unable to offer visa sponsorship.

Why should you join our team?

• We are a global, inclusive team where innovation and creativity are actively encouraged, empowering you to make a meaningful impact.
• An opportunity to develop your career in a dynamic and collaborative environment.
• Join us to embark on a journey committed to delivering innovation and improving lives.