QUAL ENG III POST MARKET SURVEILLANCE.

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QUALITY ENGINEER III POST MARKET SURVEILLANCE

Position Overview

The Quality Engineer III thrives in an environment that accepts partnership, change, risk-based decision-making and flexibility. This role predominantly performs Post Market Surveillance for the TECA (Trauma, Craniomaxillofacial, Biomaterials, and Animal Health) and the Power Tools businesses within Johnson & Johnson MedTech (DePuy Synthes). Activities include trend analyses, signal detection and investigations. The individual will execute the Post Market Surveillance process with a primary focus on signal assessment and detailed investigations and reports of potential safety issues and quality trend events. With this the individual has a direct impact on patient safety and the health of our patients, doctors, nurses, mothers and fathers.

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Tasks & Responsibilities

• This position will lead efforts in support of the business as it develops and implements product-specific safety surveillance strategies in systematic detection and evaluation of signals and emerging trends from Post-Market Surveillance data. The individual will prepare Post Market Surveillance Reports and Safety Signal Reports for Leadership as well as prepare Post Market Surveillance data and analysis for reviews with Senior Leaders and Health authorities.
• Depending upon the nature of the identified safety issue/product quality event, the Quality Engineer III will collaborate to ensure all events are raised in a timely manner as required. You will need to communicate effectively within Quality Engineering as well as cross functionally with Medical Safety, Customer Quality, Research & Development, Regulatory Affairs, Manufacturing, and Product Marketing.
• Lead in developing and implementing continuous improvements within policies and procedures and lead DePuy Synthes Operating Companies Post Market Surveillance initiatives.
• This is a hands-on position that will require an ambitious individual with excellent analytical, written and verbal communication skills. This role will have the ability to collaborate with business partners at all levels to enable risk-based decision-making.
  
  

Qualifications

• A bachelor’s degree in Engineering, Technical/Scientific, or Statistics is required. A secondary degree is helpful.
• A minimum of 5 years of experience within a quality system framework (ISO 9001 or similar) is required. Medical device/diagnostic/or pharmaceutical industry experience is preferred. Previous Design Control experience is preferred. Excellent problem solving and decision-making skills are required. Knowledge of 21 CFR Part 820 Quality System Regulation, European Medical Device Regulation, ISO s an asset.
• Advanced knowledge and confirmed use of Microsoft Excel (macros, tables, look-ups, etc.) for data analysis/signal detection is required. Experience working with large datasets is required.
• Experience with Post Market Surveillance/Signal Detection/Investigation/Root Cause/CAPA/activities is preferred.
• Minimum Language required: English fluent, German is a plus.
  
  

Our Offer

• An exciting position in an international and dynamic environment with continuous learning and growth opportunities
• A competitive salary, on-site sport accommodations, 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-Solothurn-Zuchwil-

Organization

Synthes GmbH (7111)

Job Function

Engineering

Requisition ID

2206029247W