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Quality Systems Expert
The QS Validation Expert ensures the quality oversight of the process validation activities. Main responsibility is to ensure EO sterilization validation and process validation activities comply with the applicable European and FDA regulations, guidelines, and the company’s Global Quality Policies.
Most of the time, you’ll be involved in maintaining the Process validation and EO Sterilization validation process in, more concrete:
- You’ll maintain the QMS procedures on process validation of EO sterilization and manufacturing processes, including risk management process (process FMEA) to be compliant with applicable European and FDA regulations, guidelines, and the company’s Global Quality Policies.
- You’ll supervise the EO sterilization validation engineer and train the process validation engineers.
- You’re responsible for maintaining and doing the follow-up of the VMP’s and periodic reviews to ensure that processes are timely re-validated.
- You’ll review and approve EO sterilization validation files for compliance with EN ISO 11135
- You’ll coach QA engineers in the review process of process validation files and monitor this review process.
- Follow-up EO Sterilization validation subcontractor
- Responsible for non-conformity handling related to process and sterilization validation issues (including audit nonconformities): investigate CAPA need, guide investigation to the root cause of the non-conformity and review corrective actions proposed. Ensure proper documentation and follow-up implementation of corrective actions, effectiveness evaluations for CAPA and closure of the non-conformity.
A smaller part of your time, you’ll execute and support quality systems audits
- You’ll participate in the internal audits of the company
- You’ll support regulatory, corporate and customer audits as subject matter expert for process and sterilization validation, supported by the validation engineers.
- University or technical degree in engineering, scientific, medical, or pharmaceutical oriented education, or equivalent by experience
- Experience in the technical domain of EO sterilization validation and process validation.
- Profound knowledge of EN ISO 11135, EN ISO 13485, 21 CFR Part 820, GHTF/SG3/N99-10
- Minimum 5 years professional experience in medical and/or pharmaceutical environment
- Good working knowledge of English (written and spoken). Knowledge of French is an asset.
- Team player with strong communication skills to collaborate with different partners across our organization
- Being able to work accurately according to guidelines
- Open to work full time
WHAT THE COMPANY OFFERS
Working for the company means contributing to society through healthcare.
The company offers an attractive salary and benefits package. Besides meal vouchers, interesting insurances, 100% public transport reimbursement, you also have the possibility to lease an (e-)bike.
We offer an opportunity to work in a top performing team. An organization where everyone is treated with respect. We strive to create a diverse, equal, and inclusive work environment. We invest in our associates by offering a broad array of development opportunities.
Linked with the company’s core value Care, they allow a hybrid way of working, combining office with home-based work. For this role, you’re allowed to work very flexible switching between home or office based. To ensure team connection, presence in the office is asked on Monday (morning) for weekly team meeting.
During your recruitment process, you’ll be able to have conversations with the hiring manager and other passionate associates.