Johnson & Johnson Carrières

Sr. Quality Operations Manager

Neuchâtel, Suisse
Quality Assurance

Description du poste

Requisition ID: 1805676526W

Our site in Neuchâtel is looking for a Senior Quality Operations Manager! 

Under the direction of the Quality Operation Director and with the objective of maintaining high quality standards of the product manufacturing process and compliance with regulatory requirements, administers Quality Assurance support to Quality Operations of complex site(s) and/or demanding compliance profile, and directly supervises Quality Supervisor, Team Leaders, Quality Engineers in day to day activities supporting all Business Units (Operating Companies). Partner with other quality functions, such as supplier quality and CIQE. Ensure to provide at the site adequate quality support, documentation review, and support projects, process and new product introductions or upgrading of existing processes and products and subsequent qualifications. Manage other QA Department projects as assigned.

• Ensures the quality management system requirements are effectively established and maintained, reports to top management on the performance of the quality management system and ensuring the promotion of awareness of regulatory requirements throughout the organization.
• Establishes and maintains quality assurance programs, procedures, and controls. Ensures compliance with company policies and procedures
• Ensures that performance and quality of products conform to established company and regulatory standards. 
• Carries out leading responsibilities in accordance with the organization’s policies and applicable laws including regarding health and safety.
• Provides feedback to operations on problems related to quality and/or compliance. Supports/Initiates investigations for non-conformances. Supports Operations in evaluation and implementation of actions plans to eliminate root causes of non-conformances. 
• Initiates and maintains interplant communications of quality issues.
• Supports internal audit programs. Reviews reports findings (Internal & External) and makes recommendations for corrective action.

• Manages the qualification and validation for all products and processes and quality control support activities.
• Ensures that the quality aspects for new processes, products and or upgrading of existing processes and products and subsequent validations are met.
• Acts as advisor to subordinate supervisors or staff to help meet established schedules or resolve technical or operational problems.
• Formulates and maintains quality control objectives and coordinates objectives with preproduction and production procedures in cooperation with other manufacturing managers to maximize product reliability and minimize costs.
• Provide input to design direction or product line modifications and adequacy of design and test results.
• Approves specification and process changes per applicable procedures.
• Approves the request for custom and modified standards products.
• Provides quality control support to the supplier quality assurance as requested or needed.

Continuous Improvement:
• Ensures oversight of engineers in development and deployment of innovative quality engineering tools, techniques and systems that will drive product development to successfully achieve key business. 
• Promotes the use of Process Excellence tools to enhance analytical thinking and problem solving techniques. 
• Supports on-going continuing efforts and projects to improve our manufacturing Quality Systems, processes.
• Ensures the Implementation of world-class quality engineering systems to support entire product. 

• Submits and administers budget schedules and performance standards. 
• Approves purchases and expense reports submitted by direct reports.
• Supports and promotes cost savings opportunities that work toward global objectives in the organization.

Health And Safety:
• Provides support to plant wide initiatives such as implementation of new initiatives safety, environmental and Quality related initiatives. 
• Enforces, promotes and observes all safety, industrial hygiene rules and regulations established by the Company.
• Participates and supports safety initiatives within the facility, such as emergency response, ergonomics, safe behavior program, etc.
• Reports accidents, incidents, near misses, and hazardous situations in a timely manner and participates in the corrective action process.
• Directs and administers the activities of Quality Engineers, Validation Engineers and dotted Supplier Quality Engineer and associated administrators.
• Performs Annual Performance appraisals for the identified associates. Establish objectives and development plans for direct reports or applicable processes. Recommends salary increases for direct subordinates.
• Interviewing, hiring, planning, assigning & directing work, mentoring, rewarding and disciplining employees, addressing complaints, resolving problems and issues.
• Recommends promotions for direct subordinates and interview applicants for job openings.
• Trains, coaches and develops subordinates and Quality Operations function
• Develops the the department skills in compliance, new technologies, lean and other as required
• Evaluates and recommends staffing requirements to ensure maximum utilization of personnel to fulfill department objectives

• Fosters teamwork and supports total associate involvement.
• Actively supports other plant functions in the implementation of company programs and projects.

• Other related functions as assigned
• University/Engnieering Degree or Equivalent in a Life Science, Engineering, or Physical Science.
• Trained in Quality Concept and Quality System
• Knowledge of QSR, ISO13485, CMDCAS, PAL, RDC16
• Medical device or pharma industry experience
• Team leadership
• Change management
• Strong analytical and communication skills
• Results driven, decisive, proactive, responsive skills

Further Education:
• Process Excellence / Six Sigma Certification or equivalent preferred

• Negotiation and communication skills
• Team leadership & People Management Skills
• Strategic planning
• Project and Risks management
• Quality, Lean and Six Sigma tools
• Status Quo challenge
• Independency
• Integrity
• Able to communicate and writing skills in English
• Flexibility, Serve minded
• Mathematical skills

• Site Management representative
• CO approval
• NR/CAPA/IA /DRA approval
• Performance appraisal
• Placing products/processes on hold,Product Acceptance/rejection

Emplacement principal
Medos International Sarl (7898)
Quality Assurance
Requisition ID