Senior QA Specialist
Are you an experienced Quality Assurance professional with strong expertise in ISO 13485 and GMP? Do you thrive in a dynamic environment where you guide and approve critical validation activities, lead complex quality cases, and coach junior colleagues? If you enjoy working efficient, pragmatically with a risk-based approach and want to make QA a true support function, this role is for you!
We are looking for a hands-on Senior QA Specialist to join our Quality team. This is a key position with high responsibility and direct impact on compliance and operational excellence.
As Senior QA Specialist, you will:
Ensure compliance with ISO 13485 and GMP with risk-based principles across all processes.
Coach and mentor junior QA colleagues
Take ownership of complex quality issues and drive continuous improvement initiatives, including LEAN projects.
Act as QA lead for qualification and validation of rooms, equipment’s, HVAC systems, water systems and software, guiding, reviewing, and approving activities.
Handle standard QA tasks such as deviations, change controls, CAPAs, and document reviews.
As lead auditor, perform supplier audits as well as and internal audits.
You Are:
Minimum 5–7 years of experience in QA within Pharmaceutical manufacturing and Medical Devices
Deep and practical knowledge of ISO 13485, GMP and validation principles.
Pragmatic, flexible, and solution-oriented, QA is for you a support, not a roadblock.
Comfortable with high pace and parallel tasks; quick and effective in prioritization.
Strong communication skills and a positive, collaborative attitude.
Able to work independently and proactively identify priorities.
Proven experience as lead auditor and regulatory compliance.
Qualifications
University degree in life sciences, engineering, pharmacy, or equivalent.
Solid understanding of GMP and ISO 13485 with risk-based approach.
Experience with LEAN and continuous improvement
Lead auditor certification is a plus
Certified as QP is a plus
Fluent in English and Swedish, both written and spoken
Besides competence we are a value driven organisation, and you need to share our ambition to work to make an IMPACT for patients. We know we can make a difference by setting our mind to being Innovative - Motivated - Positive - Accountable- Customer focused and work as a Team. The position is based at our office in Malmö and is a full-time position.
Interested? Send your application and CV as soon as possible, but no later than 27/3. We hold interviews on an ongoing basis and hire when we have found the right candidate.