Lead Quality Assurance and Compliance
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The Product Quality Lead will ensure exceptional communication with internal and external stakeholders, delivering high-quality products that meet regulatory requirements and customer expectations. This role involves managing quality risks, complaints, change controls, deviations, CAPAs, internal audits, product quality reviews, data training, local product release, and oversight of GDP and GMP requirements for local manufacturing, warehousing, and distribution.
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Main Responsibilities:
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* Oversee Quality Operations activities at a new manufacturing site
* Ensure compliance assurance and monitoring of manufacturing-related activities on-site
* Lead product and process quality data analysis and trends, identifying improvement activities
* Support Process Validations and Qualifications (molding, assembly, testing)
* Prepare Inspection Plans and apply appropriate AQL/RQL strategies
* Review and prepare Quality documents for batch release
* Provide comprehensive quality assurance oversight for all activities in the site
* Present quality data, trends, and conclusions to stakeholders, including customers, suppliers, and management teams
* Investigate nonconformities and failures when components, assemblies, or product specifications are not met
* Act as Quality Approver for change controls, deviations, and Corrective and Preventive Actions (CAPAs), and support Quality Control (QC) related activities
* Evaluate and investigate observed nonconformities in detail
* Apply advanced analytical and statistical techniques and methodologies when leading RCAs and CAPAs or investigations
* Support external quality inspections and execute the strategy for internal site audits
* Drive continuous improvement initiatives aimed at enhancing quality, efficiency, and effectiveness
* Minimum 10+ years of experience in Medical Device or Pharma industry in Quality disciplines
* Expert knowledge in medical devices/combination products compliance (ISO 13485, QSR, MDR)
* Expert knowledge in statistics (Trends, simulations, capabilities analysis)
* Certified Internal Auditor
* CQE certification, Black Belt in Lean Manufacturing is a plus
* Demonstrated problem-solving and critical thinking skills
* Clear / logical thinking with strong organization and communication skills
* CQT (Certified Quality Technician), CQE (Certified Quality Engineer) is a plus
* Six Sigma Green Belt or Black Belt is a plus
* Minitab skills are a plus
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Preferred Qualifications:
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* Bachelor's degree in engineering or life science
* Fluency in German is preferred
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We Offer:
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* Challenging assignments in a dynamic and innovative environment
* A multicultural team and modern working environment with state-of-the-art facilities and technologies
* A collaborative environment where a true sense of belonging fosters meaningful exchange and shared growth
* Opportunities for personal and professional development within a global organization
* Flexible hours and hybrid working policy
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