HireDiversity

Neuchâtel, CH

Compliance Engineer CDD 18 months-0000094H

Description

The Compliance Engineer will ensure the continuous implementation/improvement of Quality Compliance efforts. This individual will provide objective, independent review of the quality compliance risk by evaluating and auditing Quality Systems and taking appropriate preventive/corrective actions to ensure that Quality Systems meet the business and regulatory requirements.

Responsibilities:

Reporting to the Quality Compliance Manager, the Compliance Engineer will be responsible for:
- Be responsible for the creation, deployment, and maintenance of the internal audit schedule
- Be responsible for status updates and reporting on resource or schedule adherence challenges
- Ensure that audit procedures align with MD&D expectations
- Perform required audits in accordance with defined procedures and the master schedule; identify and perform for cause audits
- Ensure proper reporting, response review and approvals, communication of issues, and use of tracking and trending tools
- Escalate key issues to upper management as appropriate
- Trend, report and present any corrective action results/recommendations to facility management
- Provide routine communication and updates to site and franchise organizational management regarding compliance trends and initiatives
- Work effectively with the other site compliance engineers/ specialists to ensure consistent systems
- Drive Compliance improvements, which result from internal audits and provide leadership to identify and drive closure of potential compliance gaps
- Serve as a representative for internal audits during third party audits, Develop and maintain key quality and compliance performance metrics
- Promote a culture of Regulatory Compliance and Risk Management throughout the organization
- Coach and guide Quality System Auditors and support staff as required to ensure appropriate control systems are in place and continually optimized to meet changing regulatory, corporate and industry standards
- Support departmental and franchise objectives while adhering to the values of the Johnson & Johnson Credo and local safety and environmental policy and procedure
- Be responsible for the creation, deployment, and maintenance of the campus record management program in collaboration with other B.U's

This position may require international and domestic travel depending on business need and will be based at the DePuy Switzerland campus in Neuchâtel canton.

Qualifications

- A minimum of a Bachelors Degree is required, preferable in Engineering, a Life Science or a related technical discipline. Masters degree is preferred
- 4 to 5 years of professional work experience within a quality assurance or compliance audit environment is required. Experience working in a Medical Device manufacturing environment is preferred
- Qualified ISO Lead Assessor certification is preferred
- experience in conducting and/or leading regulatory assessments in an international, global context, in a regulated environment is required
- A demonstrated expert knowledge and understanding of the application of audit principles, concepts and practices related to quality systems regulated by domestic and foreign governments is required
- Prior experience of External Regulatory and/or Notified Body Inspections (e.g. FDA, BSi etc) is preferred
- Experience or training and/or certification in Process Excellence/Six Sigma is preferred.
- Strong communication, organizational, negotiation and interpersonal skills are required.
- Must have strong statistical and analytical problem solving skills
- The ability to collaborate with all levels of management across multiple sites and functions is required
- Fluent in French and English

AD CODE: J2W: JOBSCH

Primary Location:Europe/Middle East/Africa-Switzerland-Neuchâtel-Neuchâtel
Organization: Medos International Sarl (7898)
Job Function: Compliance