HireDiversity

Neuchâtel, SUISSE

Compliance Engineer-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

Exigences

· 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

Localisation principale: Europe/Moyen Orient/Afrique-Suisse-Neuchâtel-Neuchâtel

Organisation: Medos International Sarl (7898)

Fonction: Compliance