- People at our company appreciate the opportunity to shape our future and create impact.
- Encouraging leadership and inspiring ideas from our people has guided us through our proud history of pioneering innovations.
- We are currently looking for an enthusiastic Quality Assurance Specialist to join our Supplier & Packaging Compliance Team.
- The objective of this function is to ensure external suppliers’ compliance with corporate and regulatory requirements.
- The role is focusing on operational tasks in the field of quality assurance and auditing.
- Manage the supplier audit program and be responsible for the correct archiving of the documentation
- Track and assess the implementation and completion of audit related corrective actions / preventive actions (CAPAs) at suppliers
- Assess and process product related deviations and non-conformities reported via the CAPA system
- Manage the process validations at the local HQ plant and support development and production during process validations for new processes
- Define or take active part in defining qualification requirements for suppliers and coordinate the qualification process in collaboration with the supplier
- In case you possess an auditor/lead-auditor certificate, evaluate and assess the regulatory compliance status of the supplier management by performing QMS Supplier Audits
Your Profile :
- Degree in Quality Engineering (preferred) or other relevant area (engineering, science etc.; advanced graduate studies/degrees are an advantage)
- 2-3 years’ experience within the medical devices/pharmaceutical industry, desirable at manufacturing site
- Expert understanding of global medical device regulations and quality requirements as well as industry practice
- Formal qualification / training / certification on medical devices regulations such as ISO13485, USA FDA 21CFR Part 820
- Auditor or lead auditor experience in audit process is an asset, and also a development option
- Knowledge of regulatory requirements regarding the execution of audits and the maintenance of Quality Management Systems are an advantage
- Process validation experience in development and manufacturing as well as knowledge of Supplier Management and Purchasing Controls requirements are highly desired
- Proven track record in a comparable role within quality assurance and compliance
- Excellent written and verbal communication skills in German
- Excellent command of MS Word and MS Excel, familiarity with SAP is an asset
- You are someone who champions customers’ insights leading to concrete actions
- You show honesty, authenticity and demonstrate reliability
- You show the ability to be persistent and flexible and know to quickly adapt to changing demands