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)

• Conscientious / Rigorous / Analytical Mind

• Well organized and systematic approach

• Knowledge of Microsoft Office tools

• Ability to follow the flex office policy for the primary location in Le Locle

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months initially.

you are welcome here

Johnson & Johnson MedTech is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

About Johnson & Johnson MedTech

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.

For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.

application process

We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email or LinkedIn InMail - you must apply direct to this advert.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.