IT Compliance & Software Validation Officer
Location: Dordrecht

The Company:
As a global leader in the orthopedics market, Biomet is passionate about innovation and developing new technology. They specialize in the design and manufacture of implants which replace hips, knees, shoulders, and elbows, biomaterials, bone cements and accessories and orthopedic surgical instruments.

Biomet Inc is a worldwide orthopedic company with headquarters in Warsaw Indiana, U.S. Biomet employs over 6,700 team members, across 16 manufacturing facilities worldwide. Biomet and its subsidiaries currently distribute its products in 70 countries throughout the world. With annual sales exceeding $2 billion dollars they are a leader in orthopedics on a global level.

With European headquarters in Dordrecht, Netherlands and represented by subsidiaries in 22 countries across the continent, Biomet offers a specialized focus on European healthcare and orthopedics. The continual development of the highest quality, clinically proven products, together with an emphasis on education, ensures that Biomet Europe remains a trusted leading figure in the
European orthopedic market.

Department description:
The Quality Assurance and Regulatory Affairs group directs companywide efforts to assure that processes applied in the company are state of the art, efficient and meet regulatory requirements. That products and services meet regulatory requirements of the countries where they are marketed or used in clinical studies. The team provides leadership in quality system management, monitor and advise for quality aspects of products, processes and systems. And we are the independent, quality focused, proactive player in business processes.

Biomet Europe’s QA/RA group exists of the QA/RA groups in the European manufacturing locations, as in Spain, Germany, France and UK, and the QA/RA group in Dordrecht.

Job Summary:
The candidate we are looking for has ensure IT controls and compliance activities within the IT department are implemented, controlled and monitored in alignment with corporate procedures and regulations. The main focus will be supporting the SAP implementations in the Global Supply Chain Center and the manufacturing sites and subsidiaries

Tasks and responsibilities:
• Directly applying business software validation strategies in relation to software projects.
• Ensure IT process quality and sustainable compliance to regulatory requirements, such as FDA (inc. GxP), SOX, Data Privacy, Security, and IT control processes.
• Provide external auditors with all IT controls, documentation and testing results.
• Ensuring quality of software developed and released.
• Serve as member in the Global IT Controls Team.
• Perform periodic reviews of established IT Controls.
• Manages creation of consistent validation documentation and a scalable approach to computerized systems validation. Implement the overall software validation process within Biomet Europe and its subsidiaries.
• Manages validation team members throughout the products/project system life cycle.
• Takes ownership of the templates (SLC) of Standard Operating Procedures and validation documentation.
• Review and approve test scripts and traceability to requirements for projects under validation.
• Continuous improvement of the validation process through new business software implementations, such as complaint handling and document management systems.
• Closely interacts with the Business and IT department
• Assess the documentation needs for software development

Profile of suitable candidate:
• Engineering or University degree or equivalent in an IS related discipline
• At least 2 years of experience in software engineering
• Experience in QA & RA in de Healthcare industry
• Experience with testing (test methodology, writing of test cases, test tools)
• Experience in an international environment
• Broad knowledge/experience in Medical Device development
• Experience in Project management
• Development of policies, SOPs and associated documents
• Must be able to identify and assess risks, monitor the level of risks on an ongoing basis, and recommend solutions for risk mitigation to business owners.
• Be able to apply new tools and technology to improve IT audit processes and employ monitoring metrics to report on compliance status
• Knowledge of IT Controls and regulatory requirements
• IT systems and applications (SAP R3)
• Excellent communication skills and fluent in written and spoken English and Dutch
• Medical Device industry regulatory compliance
• Travelling is involved in the position

Salary
Biomet offers you a challenging position with good career prospects in a fast growing international business. We offer a competitive remuneration package, good pension plan, bonus scheme, telephone and laptop.

Apply
If you are interested and you meet all the above requirements, sent your resume with a motivation letter to: Guy Laeven, International Recruitment Coordinator by using the link below (copy and paste the link in your internetbrowser):



Or apply by using the 'Apply on company webiste' button.

Please state the Job title in the subject.

For more information about Biomet: www.biomet.com or call Guy Laeven: 078 – 629 29 19

Acquisition is not appreciated - Acquisitie wordt niet op prijs gesteld

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