Senior Quality Assurance Specialist

2 weken geleden


Eindhoven, Noord-Brabant, Nederland NLwerkt Voltijd
About the Role
This opportunity is a great chance to collaborate with cross-functional teams and ensure the safety and quality of medical devices, directly contributing to global patient care and customer satisfaction.

Key Responsibilities
The role entails driving the Correction & Removal (C&R) strategy and ensuring compliance with global regulatory standards. You will also be responsible for preparing documents to support critical C&R decisions, including Health Hazard Evaluations, as well as creating and managing all C&R-related customer notifications and regulatory submissions (e.g., FSCA, 21CFR806). Additionally, you will manage C&R documentation to meet Good Documentation Practices, support responses to inquiries from regulatory agencies, continuously track C&R progress and share updates with stakeholders, and engage with C&R teams to improve processes continuously.

About NLwerkt
We are committed to providing our employees with a competitive compensation package, which includes a good salary, paid out periodically pro rata, holiday pay calculated over 12 monthly salaries, and an 8.33% bonus. We also offer a one-year contract, a pension scheme, a home workplace allowance, 25 days of vacation per year based on 40 hours, travel expenses reimbursement, options for working from home with a home work allowance, a training budget of up to €3,500 per year, referral bonuses up to €1,500, a fixed HR contact person, a professional buddy, and knowledge & networking events.

Salary and Benefits
The estimated salary for this position is around €60,000 per year, depending on education and work experience. The salary will be discussed during the interview process.

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