PR: *** (Please do not post the PR in the job sites)
BR: *** (Max)
Hybrid - 3days oniste and 2days offsite
Responsibilities:
- The primary responsibility is managing the ETE IVDR/MDR product verification process for products within Roche's distributed products portfolio, including determining requirements and controls for those products and completing objective evidence of supplier evaluation and approval.
- Manage SCARs (Supplier Corrective Action Requests) and successfully complete them, as well as address other supplier gaps in a timely manner by tracking robust corrective action plans.
- Complete onboarding activities for suppliers.
- Monitor supplier performance.
- Plan and follow up on supplier audits and ensure resulting supplier actions are sufficient to resolve quality issues and are completed in a timely fashion.
- Identify and escalate issues as they arise and provide adequate solutions.
Must Have:
- Two or more years of experience in Quality or a related function.
- Bachelor s / Master s degree in Life Science, Data Science, or a related subject or equivalent experience.
- Professional experience in a similar role within the medical device sector.
- Knowledge of deviation and resolution management.
- Expertise in quality systems, standards and regulations, specifically production and/or supplier development processes and standards such as ISO 13485 and ISO 27001.
- Strong analytical skills with a focus on essential facts.
- Excellent communication skills.
- Cultural awareness and experience interacting with global internal and external partners and suppliers.
- Leadership mindset with the ability to lead others within an agile organization.
- Willingness and flexibility to collaborate cross-continentally in a global team across different time zones (may require early working hours to ensure close collaboration with colleagues in the European Union).
- Decisive and able to initiate and complete daily activities and proactively find solutions independently with limited guidance.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.