Description
We are looking for a
Senior Quality Assurance Specialist (m/f)
Reference: -en
Start: asap
Duration: 6 MM
Place: in Hesse
Branch: Medizintechnik
Your tasks:
- Responsible for quality oversight of IVDD production and product release, evaluate release testing against requirements, coordinate sample submissions to notified bodies to support product testing and release
- Complete batch record reviews
- Interact with contract manufacturers and act as a quality point of contact for suppliers
- Actively communicate with supply chain, production, marketing/commercial operations concerning product release timelines or status of quality issues
- Serve as subject matter expert (SME) for quality systems (i.e., Deviation Management, Corrective and Preventive Actions (CAPA), Trending, Management Escalation, Product Release, etc. )
- Make quality decisions including but not limited to determination of a quality deviation, product hold, stopping operations, etc. based on the specific circumstances that could affect product quality
- Ensure all manufacturing and packaging are in compliance with Regulatory standards
- Perform root cause analysis and implement CAPAs for quality related concerns
- Identify and implement quality key performance indicators, develop benchmarks, measurements, quantifiable benefits and track progress for areas of responsibility
- Foster a continuous improvement culture by collaborating with other organizations in alignment with Quality strategic objectives
- Review and approve documentation including but not limited to OOSs, deviations, root cause investigations, CAPAs, protocols, reports, procedures, change orders, etc.
- Function as data protection officer
Your qualifications
- Bachelor’s degree in chemistry, biology, engineering or other related scientific discipline
- Profound experience in a quality assurance role supporting batch release, non-conforming material reporting, CAPA, vigilance
- Ability to apply knowledge of ISO 13485, IVDD and cGMP standards to the job
- Proficiency in product release and ability to function as a Qualified Person
- Fluent in English and German – spoken and written
- Excellent communication skills
- Ability to function in a team environment
Skills:
- Quality manager
Keywords: Qualitätsmanager