Quality Assurance Manager
As a Quality Assurance Manager, reporting to the COO, you are responsible for the implementation, maintenance and continuous improvement of the OnDosis quality management system, based on ISO 13485, EU Medical Device Regulation, and US Quality System Regulation (CFR Title 21, Part 820).
You provide guidance and support quality operations throughout the product lifecycle (from pre- to post-market phase) to ensure product quality and adherence to quality management procedures and regulatory compliance.
Your responsibilities include:
- Lead quality aspects of core projects.
- Manage corrective and preventive actions program, non-conformances, complaint handling, risk management activities, etc., through development, maintenance and adherence to documented processes.
- Promote awareness of quality aspects throughout the organisation and perform/coordinate training in quality management processes.
- Responsible for organising management reviews and compiling/reporting on the performance of the quality management system.
- Plan and manage audit activities.
- Responsible for supplier evaluation, overseeing and directing subcontracted manufacturing, including coordination of external audits.
- Responsible for establishing and maintaining quality agreements with pharma partners and subcontractors.
Are you the one we are looking for?
We are looking for talented professionals with passion and drive. You have a strong attention to details and a quality-oriented mindset. Dealing with many internal and external stakeholders, you have excellent communication skills in English (both written and spoken).
As a Quality Assurance Manager, you have:
- Relevant experience from a quality assurance position in medical devices.
- Demonstrated knowledge of relevant regulations, international standards and guidelines, such as ISO 13485, ISO 14971, MDD, MDR, CFR Part 820, MDSAP.
- Comprehensive experience from developing and delivering effective quality management processes is preferred.
- Good working experience from risk management is meriting.
- Experience from regulatory assurance role in medical device or pharmaceutical industry.
- Experience from drug-device combination products is considered an advantage.
What can OnDosis offer you?
You will have a great opportunity to join early and develop in a company which acts on the global arena with really high ambitions. Our clients are large multinational pharmaceutical companies. Your colleagues are all highly skilled professionals with a profound industry knowledge. The commitment to establish a new standard for the dosing of medicines is present in everything we do. For sure, you will be part of an exciting growth journey on the global pharma- and medical devices arena.
This recruitment is handled by our recruitment partner, Moveup Consulting AB. To apply, please send your CV and a cover letter to email@example.com
If you have questions regarding OnDosis or this open position, please contact Tom Bergqvist at +46 (0)733 87 27 22 or firstname.lastname@example.org
By submitting your application, you also consent to us storing your personal data, including CV & cover letter and that we have the right to share this information with third parties (our client). You can revoke the consent whenever you want.
Founded as a spin-out from AstraZeneca in 2017, OnDosis is a Swedish start-up addressing one of the major opportunities in healthcare; personalized dosage of medicines. The proprietary technology platform is centered around a connected handheld dosing device that delivers tailored doses of oral medicines. By combining individual dosing of traditional drug-based medicines augmented by digital therapeutics, OnDosis opens a new chapter in personalized medicine where the mission is to improve patients’ life through delivering the perfect dosage; individualized, intuitive, and intelligent. OnDosis is based in the AZ BioVenturehub in Mölndal, Sweden.