Compliance Engineer

Job type:
Quanta Consultancy Services
flag_no Germany
project ID:

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This is an exciting, long-term opportunity for an experienced Compliance Engineer to support a medical device company based in Germany.
The successful candidate will support the site gap assessment and implementation plans for combination products regulatory requirements. This role 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.

Location: Northern Germany, Germany. This position may require up to 10% travel.
Start: 2nd February 2015
Duration: 12 months - until 31st January 2016

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!

Additional Job/Position requirements:
• 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 preferred.