Beschreibung
We have an exciting opportunity for an experienced Compliance Engineer reporting to the site Quality Systems and Compliance Lead. The successful candidate will support the site gap assessment and implementation plans for combination products regulatory requirements. It will be in an international environment/team, as they align the QS/Regulatories with other sites in other countries that produce or package the same products. Principal Duties and Responsibilities: * Lead the execution of the site gap assessment for combination products (i.e. coated threads) * Lead, along with the project Quality Engineer, the implementation of the site action plan to comply with the combination products regulation * Lead the execution of quality systems requirements during the implementation of the action plan, including but not limited to the internal audit program, document management process, document reading process and records management, using global software applications and Excel * Execute internal and site criss cross audits to relevant, Franchise, Enterprise and Regulatory Standards: * Provide training and support to site partners to ensure the successful and timely completion of implementation activities * Provide Subject Matter Expert support during audits as applicable. * Provide Quality subsystem process performance measurements to Quality and Operations Management as required * Provide periodic updates of the implementation to senior management. * Work effectively with other Quality and Operations associates to ensure consistent and compliant Quality subsystems * Work effectively within the regional compliance team, and the sector compliance team, to ensure consistent/effective project deliverables Required Education, Training and/or Experience * Knowledge of Quality Systems Standards (BS EN ISO13485; FDA Medical Devices Quality Systems Regulation 21 CFR 820; Medical Device Directive 93/42/EEC) * GMP knowledge requested! * Important to have knowledge of Quality Systems standards for Pharmaceutical!! or Biological products * Knowledge of equipment and test method validation processes essential. * Knowledge in database administration and data manipulation for analysis and reporting purposes * Desirable to have a degree in Life Science, Physical Science, Engineering or equivalent * Desirable to hold a recognised Internal/Lead Auditor Certification and/or extensive or experience in executing audits, people with experiences in internal audits preferred! Location: * This position will be located at Norderstedt and may require up to 10% travel (may be to Scotland or US) , team onsite for several quality tasks: 7+3 people. some will be in the same project. Additional Job/Position requirements: * Apply Credo values in an open and ethical manner and promote CREDO values within the QS&C and site teams. * Excellent written and verbal communication skills with an open, collaborative, interactive style with a good team working ethos * Balanced decision-making * Strong collaboration and influence management skills to partner effectively across functions * Use facts and rational arguments to influence and persuade * Fluent German and English preferredMost important: as the product (coated thread) is coated with a pharmaceutical material, you need to be someone that knows the regulatories of pharma by heart to be able to find the GAPs and execute the QS requirements/validation planning! Best would be with internal audit experiences and English+German needs to be fluent. Production knowledge in Med Devices preferred, as well as knowledge with Incident Man. Systems.