Senior Supplier Quality Engineer - Johnson and Johnson

Johnson & Johnson Surgical Vision, part of Johnson & Johnson Family of Companies, is recruiting for a Senior Supplier Quality Engineer, located in Milpitas, California.

At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That's why, through our operating companies, we've developed solutions for every stage of life-to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world's leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good, and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.

The Senior Supplier Quality Engineer provides overall quality assurance leadership, serving as supplier-related QA technical and compliance lead for pre- and on- market product by ensuring the outsourced activity and associated product is qualified for use by the business unit.
Key Responsibilities:

• Actively participate on cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations.
• Participate in local site supplier and External Manufacturer (EM) quality meetings to ensure communication and alignment of quality initiatives and objectives.
• Support internal and external cross-functional and cross sector project teams driving supplier/EM improvement through both reactive and proactive engagements to reduce process variation and improve capability.
• Provide internal and third-party inspection support. Accountable, as applicable, for compliance in accordance with regulations such as and from, but not limited to, FDA 21 CFR 820, ISO 13485, EU MD Directive/Regulations, Japan PAL, Canada CMDCAS, Brazilian ANVISA, and Australian TGA for assigned products.
• Support internal and lead supplier root cause investigations and corrective actions. Lead defect resolution, root cause investigation, and continuous improvement activities.
• Collaborate across functions to confirm if non-conformances are supplier/EM related as applicable.
• Monitor and report supplier and internal performance & quality metrics and support product/process improvements.
• Support product development by ensuring suitability of internally-developed specifications, instructions and test methods and leading the design transfer to the supplier, including providing QA technical and compliance expertise for risk analysis/assessments and process/test method validations.
• Participate in 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.
• Monitor compliance with company policies, procedures and applicable regulatory requirements.

Education:

• A minimum of a Bachelor's Degree is required. Focus degree in Engineering, Electrical, Mechanical or Industrial or related science/technical field or an equivalent is preferred.

Experience and Skills:

Required:

• A minimum of 5 years of work experience within FDA regulated industry (Biotech, Pharma or Medical Device manufacturing)
• Basic understanding of the Medical Device Quality Systems
• Working knowledge of Word, Power Point and Excel with proficiency in moderately complex functions for data analysis and trending
• Excellent written and verbal communication skills

Preferred:

• Able to review technical documentation for acceptability in a variety of formats (e.g. internal documents, supplier documents, Technical drawings, validations, change records, inspection reports).
• Experience with SAP
• Experience leading meetings and strong presentation skills.
• Experience working with Electrical, Mechanical, Chemical, Packaging, Plastics or other manufacturing
• Understanding of FDA, ISO and International Quality System regulations (such as 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; Canadian CMDCAS; Japanese PAL; Brazil ANVISA, Australian TGA, and EU MDR)

Other:

• This role may require up to 25% of domestic and/or international travel.

The anticipated base pay range for this position is $76,000 to $121,900. In the Bay Area, the anticipated base pay range for this position is $89,000 to $140,185.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.