Senior Design Quality Engineer

Job content

"Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo

Senior Engineer Design Quality

Position Overview

Working in the Design Quality team the qualified candidate for this hands-on position should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. This individual should be willing to make a significant contribution to a multi-discipline team, must be self-motivated to take action, and have excellent written and verbal communication skills. Located in Oberdorf (BL) this position will also provide technical quality engineering leadership to the business in order to ensure the highest levels of product quality, process, and systems integrity to the end customer.

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Tasks & Responsibilities

• Design Quality team member focused on Life Cycle Management activities and/or NPD.
• Provides leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc.
• Provide leadership in the understanding of medical device regulations to other disciplines.
• Communicate effectively at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing and in some cases Suppliers.
• Enhance the Design Control and Risk Management processes to better reflect state of the art practices and drive continuous improvement Review project deliverables (e.g. plans, requirements, specifications, test results, risk management documents, reports).
• Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes. Perform Gage R&R studies.
• Conduct and lead design verification and validation activities.
  
  

Experience

• Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process Failure Mode and Effects Analysis is preferred.
• Previous experience in a medical device or a healthcare discipline is required.
• Working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDR 2017/745, MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is preferred.
• Working knowledge of material science, blueprint reading/literacy including GD&T and mechanical product knowledge is preferred.
• Previous experience implementing Quality System improvements to meet compliance and overall business goals is preferred.
• Proficiency with the Microsoft Office Suite is required.
• Development and/or manufacturing experience is preferred.
• Knowledge of process and design excellence tools is preferred. Process Excellence certification is an asset.
  
  

Skills

• Excellent problem solving, decision-making, and root cause analysis skills are required.
• Analytical & Critical thinking
• Ability to digest, process, summaries complex content
• Interpersonal skills that foster conflict resolution are required.
• Ability to manage multiple projects/priorities is required
• Ability to work in a team setting within Design Quality and cross-functionally is required
  
  

Qualifications

• A minimum of Bachelor’s degree in engineering or related technical or scientific discipline with a minimum of 4 years of experience in related field is required.
• A Master’s degree in a technical disciplinary is an asset.
  
  

Language

• English: Business fluent required
• German: Basic knowledge preferred
  
  

Our Offer

• An exciting position in an international and dynamic environment with continuous learning and growth opportunities
• A competitive salary, J&J flextime, health/energy programs and other benefits for you and your family.
• An inclusive team environment where diversity and different opinions are respected and valued, and the importance of a good work-life balance is recognized.
  
  

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.

Primary Location

Switzerland-Basel-Country-Oberdorf-

Organization

Synthes GmbH (7111)

Job Function

Engineering

Requisition ID

2206074718W