Beschreibung : Quality Systems Manager, CQ MedTech EMEA. Unternehmen : Johnson & Johnson. Lage : Zug, ZG

&J MedTech EMEA Commercial Quality is recruiting for a QS Manager, located in any MedTech EMEA region office .

The QS Manager is responsible for the management and execution of the EMEA CQ regional QMS and manages direct reports if applicable.

The role will interface with business partners and related organizations to ensure a consistent and systematic process is followed and that metrics are reported timely.

Lead & support continuous improvement activities with regards to areas of responsibility.

Quality Systems Manager, Commercial Quality MedTech EMEA (f/m/d)

Key Responsibilities :

Establish, support, and sustain the EMEA Quality System by the following responsibilities with focus on Audit/Inspection Management (Internal & External), Quality Manual management and regional ISO 13485 certification:

• Define, deploy, and maintain the CQ EMEA regional Quality Management Systems (QMS)

• Manage the implementation and administration of the Quality Management Systems in accordance with applicable standards.

• Accountable for the management of assigned Quality System processes e.g. document & record management, training management, quality agreements, change control, audit, Purchasing controls, CAPA etc.

• Serve as an SME (Subject Matter Expert) for the assigned Quality System processes e.g. Document & Record Management, Training Management, Quality Agreements, Change Control, Purchasing Control, Audit & Inspection, CAPA etc…

• Provide guidance and support and coaching on assigned processes & systems

• Ensure adequate communication of quality compliance needs and status to all affected sites/organizations.

• Ensure timely and consistent reporting of metrics and KPIs (Key Performance Indicators) associated with assigned processes

• Drive simplification, standardization, and continuous improvement of processes across the EMEA region

• Provide regional audit/inspection readiness support.

• Manages and provides guidance to direct reports where applicable

• Builds strategic partnerships regionally and globally, and support / develop of solutions and ensure implementation with region.

• Monitors compliance with company policies and J&J quality procedures

• Evaluate quality processes and recommend improvements to meet regulatory requirements

• Perform other related duties as required

Qualifications A minimum Bachelor’s degree in engineering, scientific, business or QRC disciplines. Will accept the equivalent relevant industry experience if no degree. Experience and Skills:

• Compliance experience, QMS experience.

• Change management and project management experience.

• Strong presentation skills.

• Collaborative approach, team player.

• Managing complexity, working in a matrix organization.

• Detailed understanding of QM Systems and local/regional (EMEA) Medical Device regulations.

• +8 Years experience in regulated industries; medical device / pharma / consumer.

• Experience with ISO certification, Notified body; Health authority inspection experience.

• Demonstrated critical thinking capabilities, ability to help define a vision for the future.

• Understanding the linkages in Quality and Regulatory compliance in delivery to customer and health authority.

• Ability to translate strategy to execution and drive the organization forward in executing and delivering results

• Excellent level of spoken and written English

• Supervisory experience desirable

Key competencies required:

• Coordinating and interacting with multiple and diverse stakeholders.

• Well organized.

• Risk based and strategic thinking.

• Ability to influence and negotiate with business partners and authorities.

• Excellent communication skills, able to inspire trust and quickly build credibility.

• Strong collaboration and influence management skills to partner effectively across functions and operating units.

• “Hands-on” approach.

• Accountability, with a strong desire to commit. Recognizes and builds support for change. Engages in constructive conflict.

• Ability to fit in well culturally in a complex organization.

Other:

Language: English – fluent

Travel: ~20% - domestic & international as necessary

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.