Quality Engineer II, Quality System

Job description

Johnson & Johnson Vision Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer II to be located in Milpitas, CA.

Johnson & Johnson Vision (JJV), is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, and through the acquisition of Abbott Medical Optics in 2017, no other manufacturer has matched the aggressive expansion of our wide-ranging Surgical Vision (Cataracts and Lasik portfolio) and Vision Care (ACUVUE and Consumer Eye Health solutions) family of products. Our associates around the world are committed to expanding the J&J Vision brands brand, and fortifying our position as the worldwide leader in total eye healthcare solutions.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. 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.

You, The Quality Engineer II will:
· Be responsible for compliance with applicable Regulatory Requirements, JJSV policies and procedures.
· Provide QA technical and compliance expertise in establishing and assuring quality system objectives.
· Perform activities such as Management Review preparation,
· Support site inspection readiness activities, procedure development/update, process improvements and quality metric reporting.
· Plan, execute, report and follow-up on Management Review actions, CAPA actions, NCR or Audit Observations
· Actively participate on cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations.
· Monitor compliance with company policies, procedures and applicable regulatory requirements
· Track and report progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans
· Assists department and project leaders in developing and reporting appropriate performance and quality metrics

The Quality Engineer position is accountable to the Quality Assurance Manager/Director for achieving mutually agreed upon objectives. The position must assure that adequate data is available to support compliant Quality System. Decisions and recommendations made by this position directly impact on the quality of marketed products for domestic and international sales. The position is for Quality Professional with full understanding of the business and compliance priorities who is able to function with little to no supervision. Appropriate management consultation will be sought when policy decisions are involved with a major impact to the business, site, or division.

Desired profile

Qualifications :

·  A Bachelor's Degree and a minimum of 4 years' experience in an FDA regulated industry is required.
·  A degree in Engineering, Chemistry, Biology or related science/technical field is preferred.
·  Medical Device experience is preferred.
·  Experience with Quality Systems based on 21 CFR 820 and ISO 13485 Quality System Requirements is required.
·  ASQ or Industry Recognized Certification is preferred.
·  Hands-on knowledge of computer applications including use Word, Excel applications, and presentation software such as Power Point is required.
·  Excellent written and oral communication skills is required.
·  Excellent organizational skills and presentation skills is required.
·  Works well in a team-oriented, cross-functional environment is required.
·  Ability to handle multiple tasks and operate in a fast-paced environment is required.
·  This position will be located in Milpitas, CA and may require up to 10% domestic and/or international travel.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.