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Staff Quality Engineer- Reliability
Requisition ID: 5041180305
Johnson & Johnson Vision Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Quality Engineer- Reliability 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 Staff Quality Engineer - Reliability will:
- Provide QA technical and compliance expertise as part of development teams in establishing and assuring product quality objectives.
- Assure compliance to applicable regulations.
- Perform quality activities such as audits, procedure development, product release, documentation review and define changes to controlled documents. Provides QA technical and compliance support for exiting products and manufacturing sites related to suppliers, corrective and preventive actions, product/process improvements and training
- Be Responsible for compliance with applicable Corporate and Divisional policies and procedures
- Plan, execute, report and follows-up on quality system audits (supplier and internal)
- Actively participates 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
- Make decisions that are aligned with management objectives regarding work processes, plans and schedules in order to achieve department objectives
- Track and report progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans
- Resolve project issues by working with team members, project customers, and others as appropriate
- Assist department and project leaders in developing and reporting appropriate performance and quality metrics
You, the Staff Quality Engineer - Reliability 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 product claims, and that all design objectives are properly stated and verified. Decisions and recommendations made by this position directly impact on the quality of marketed products for domestic and international sales. The position is for an entry level 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.
- A Bachelor's Degree in Engineering, Chemistry, Biology or related science/technical field or an equivalent combination of education and work experience is required.
- A Master’s Degree in Engineering is preferred.
- A minimum of 6 years’ of experience in an FDA regulated industry (Biotech, Pharma or Medical Device manufacturing) is required.
- Auditor certification from an industry recognized organization is preferred.
- Hands-on knowledge of computer applications including use of the Internet, Word and Excel applications, and presentation software such as Power Point is required.
- Knowledge of Agile, SAP and/or ETQ is preferred.
- Excellent written and oral communication skills are required.
- Good organizational and good presentation skills are 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.
- Experience with electro-mechanical equipment is preferred.
- This position will be located in Milpitas, CA and may require up to 10 % domestic and/or international travel.
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