Primary Quality Systems Specialist

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Job Description

The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Primary Quality Systems Specialist.

The CSS Group consists of multiple businesses including Acclarent, Biosense Webster (BWI), Mentor, Cerenovus (Codman, Pulsar, and Neuravi), and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Electrophysiology, Surgical and Non-Surgical Aesthetics, Neurovascular and Reprocessing. The CSS Group is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world. Our customers and the patients they treat are our first priority and these values are reflected in Our Credo, which guides our daily decisions and actions. Our relentless commitment to Quality and the principles that define us in Our Credo have helped us achieve significant milestones and continues to help us deliver significant growth year after year!

You will provide quality systems guidance and support for development, maintenance and enforcement of compliance with the company-wide quality management system for Cerenovus. This position will collaborate closely with business partners to provide leadership with regard to Quality System standardization and execution activities to ensure activities are aligned with J&J Medical Device Segment requirements, J&J Enterprise Standards, and regulatory requirements.

  • Serve as a Quality Systems subject matter expert
  • Track and report action plan status/completion, in relation to quality systems improvement efforts
  • As needed, assist with creation and modification of Quality System procedures, work instructions and related documentation
  • Monitor and report metrics, and take action to drive improved performance
  • Facilitate Quality System Management Review
  • Serve as site lead for CAPA and Non-conformance
  • Support product issue assessments and Field Actions.
  • Work on investigations and coordinate associated teams
  • Drive compliance with external standards and regulations, including requesting, monitoring, and completing gap assessments
  • Identify and act on opportunities to continuously improve quality systems and processes in alignment with overall quality and business objectives.
  • Support and participate in projects when assigned/appropriate.
  • Provide back room support for 3rd Party Inspections and Audits (e.g. Registrar, Notified Body, FDA, MDSAP, or customer audits).

  • A minimum of a Bachelor’s Degree is required
  • A degree with a concentration in Math, Science, Engineering or Business discipline (Management Science, Operations Research, Business Administration, Software and or an advanced degree is preferred
  • A minimum of 2 years in Quality Engineering, Quality Systems or Quality Assurance work experience is required
  • Experience in an FDA regulated industry (medical device, pharmaceutical, etc.) is preferred.
  • Working knowledge of 21 CFR Part 820, ISO 13485, ISO 9001 and familiarity with ISO 14971 is preferred
  • Broad-based technical knowledge and experience is preferred.
  • Ability to work effectively with others in diverse areas of business is required.
  • Ability to effectively prioritize and lead multiple activities is required.
  • American Society for Quality (ASQ) CQE, CQA, CMQ/OE, CSSGBB, CSSBB, or equivalent professional credential is preferred.
  • Must be able to travel up to 15% domestic and/or international travel.

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
United States-Florida-Miami Lakes-
Biosense Webster Inc. (6010)
Job Function
Requisition ID