Quality System Engineer

Quality System Engineer

Location: Le Locle

Working mode: On-site

Hours: 40 hours per week

Contract duration: 12 months

Imagine your next project overseeing Legal manufacturer site Document Control and Change Control activities, ensuring all business and regulatory requirements are met for an iconic global healthcare company.

This position falls under the Quality JobFamily Group and Quality System JobFamily, supporting Medos International Sarl in Le Locle, Switzerland.

The successful candidate will oversee Legal manufacturer site Document Control and Change Control activities, including management of change documentation for the duration of changes, and on-site administration of the change control system to ensure all business and regulatory requirements are met. They will support site readiness in the deployment of initiatives, as well as the compliance and continuous improvement of the Quality System.

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position reports to the Quality Systems Manager - Legal Manufacturing (LM). Company management reserves the right to add, delete or otherwise alter assigned duties at any time. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The minimum qualifications listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

roles and responsibilities

Quality System

• Review quality and regulatory documentation
• Support external and internal audits preparation (logistic, organization of FR and BR, material order…)
• Supports compliance activities by participating in audit readiness; assisting in Internal and External audits; supporting the investigation, response, and remediation of site-specific QS audit observations
• Determines root causes of quality issues and develops corrective actions and recommendations
• Create certificate of analysis when requested
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Document Management

• Ensures consistent and correct execution of change management procedures at the site to maintain the quality and compliance of the process and the records for document creation and changes. This includes: review site change request and change order documentation; provide guidance/ training on Document management tools and requirements; assist users with documentation, actions and justifications; assist with selection of assessment owners and approvers
• Drives timely and compliant execution of document changes by driving cross-collaboration across functions, monitoring progress, and elevating issues in a timely manner for resolution
• Supports the Document Control process initiatives impacting the site (e.g.: local procedure update, document translation, cross-operating companies harmonization and process streamlining) and ensure continuity of the application of processes and systems at site level

how to succeed

• University/Bachelor’s degree or Equivalent
• Knowledge / experience of medical or technical industry
• Previous experience in Quality System
• Fluent in French
• Fluent in English
• Ability to communicate at different levels of the organization, and to interact with and influence cross-functional and cross-business teams to drive results (negotiation skills)
• Conscienti