Quality Engineer

Biosense Webster, Inc., part of the Johnson & Johnson Family of Companies, is a global leader in the science of diagnosing and treating heart rhythm disorders. The company partners with clinicians to develop innovative technologies to improve the quality of care for arrhythmia patients worldwide.

We are looking for a Quality Engineer to join our talented team and support product development processes!

Responsibilities:

• Supports Supplier and Operation Quality activities during product development, including design changes and assessment and transfer from R&D to production

• Drive Supplier Quality performance, including new product development and product Quality Improvement.

• Supports Non-conformances, Corrective and Preventative Actions, Audits, Training and Quality System activities as needed and ensures compliance

• Supports Product Development process compliance; verify that product is being tested per applicable standards and essential requirements are met, and product is properly being transferred to manufacturing and initiate product improvements

• Supports Risk Management methodology and problem investigation

• Supports and implements quality processes and standards for new product introduction (including internal Johnson & Johnson standards and processes)

• Serves as Extended Team Member on Product Development Projects; Leads Quality activities for tools and jigs development

• Review and approval of ECO's – from QA point of view

• Promote Initiatives to improve Quality processes and behaviors

• Performs other duties assigned as needed

Requirements:

• Bachelor’s Degree in Engineering or related science field

• CQE - advantage

• 3-5 years of related QA work experience, including Supplier Quality experience

• New product development experience from the medical device industry or other highly regulated fields.

• Strong Technical skills

• Good English skills (write\speak)

• Big picture orientation with attention to detail

Comments:

Employment by an outsourcing company.

Biosense Webster is an equal opportunity employer promoting diversity and inclusion in the workplace.

This position may be suitable for any person subject to their qualifications and capabilities, regardless of (inter alia) gender, origin, ethnicity, sexual orientation, and/or disability.