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Senior QA Specialist

Magle Group
Full-time
On-site
MalmΓΆ, Europe, Sweden
Senior QA Engineer

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.

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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 MalmΓΆ 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.