At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

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Johnson & Johnson is currently recruiting for a Staff Supplier Quality Engineer! This position will be located in Anasco, PR.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com/.

Position Summary:

Provides team leadership to Supplier Quality through cross-functional collaboration with procurement, operations quality assurance, engineering, and with suppliers. Supports and sustains robust supplier management programs for designated manufacturing and development activities. Supports department projects and investigations relating to Supplier Quality issues. Provides overall quality assurance leadership in the management and qualification of suppliers. Establishes and maintains quality assurance programs, procedures, and controls, ensuring that performance metrics of both the supplier quality systems and suppliers are continually measured to drive improvement initiatives. This position aids in the identification and elimination of supply chain risks via internal and supplier partnerships. Leads/participates in supplier engagements to assess technical competency and general compliance to requirements, i.e. material specifications, Critical to Quality attributes, process control plans, quality agreements, etc. Key areas of focus within supplier management are performance monitoring/reporting, compliance to J& J standards and streamline processes. Key areas of support provided to team members include risk management/communication, defect resolution, process capability/process improvement, and quality assurance general support.

Key Responsibilities:

• Performs quality processes including change control, supplier non-conformance, quality agreements. Participate in local site supplier quality meetings to ensure communication and alignment of quality initiatives. Lead supplier quality evaluations. Provide third party inspection support.
• Lead defect resolution, root cause investigation, and continuous improvement activities. Collaborate across functions to confirm if non-conformances are supplier related as applicable.
• Support internal and/or external cross-functional and cross sector project teams driving supplier improvement and general initiatives through reducing variations in supply chain, institute control plans, and improving process capability. Provide Quality Engineering support to suppliers including verification/validation activities. Apply Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Fault Three Analysis (FTA), Root Cause Analysis, Design of Experiment (DOE) etc., to the development of new products or processes related to raw materials, services, and finished products.
• Accountable, as applicable for compliance in accordance with regulations such as and from, but not limited to, FDA Quality System Regulation, ISO 13485, EU MD Directive/Regulations: FDA, 21 CFR 820; FDA Combo Product Regulation 21 CFR Parts 4 with 21 CFR 210/211, Japanese MHLW, Health Canada, Brazilian ANVISA, Australian TGA for the company's products including medical devices and combination products.
• Maintain, support compliance of, and improve supplier/EM quality processes, including procedural and electronic systems. Support alignment with enterprise standards and executing gap assessments. Provide regulatory guidance and interpretation to internal and external partners with regards to the following areas: Supplier Quality procedures, medical devices, and combination products.

• Evaluate processes to determine if refinements would enhance speed of results and productivity.

• Share ideas on how results can be achieved more quickly.

• Examine the quality of products and customer service. Identify steps to improve in these areas.

• Build & reinforce a sense of urgency on key projects; help others understand the criticality of these efforts.

• Listens and responds effectively, seeks clear requirements, and follows up in a timely manner.

• Develop relationships with internal partners including Procurement/ Sourcing, Planning, Material and Supplier Engineering, Quality Assurance, R& D, and suppliers.

• Review Supplier Quality procedures and consider new ways to enhance effectiveness and share feedback with the process owners.

• Find ways to challenge the status quo and how things have always been done; bring new ideas or innovations to bear on existing efforts

Qualifications:

Education:

A minimum of a Bachelor’s or equivalent University degree is required with a focus in Engineering, Life Science or related technical field preferred.

Required:

• Minimum of 6 years of experience as a professional in a regulated industry, preferred Medical Device
• Demonstrates a basic understanding of the Medical Device Quality Systems, emphases on purchasing controls.
• Require working knowledge of Word, Power Point and Excel with competency in moderately complex functions for data analysis and trending.

Preferred:

• Experience in the Medical Device industry is preferred. Experience in the Pharmaceutical industry or Chemical, Packaging, or Plastics industry is an asset.
• FDA and ISO regulations knowledge. 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; Canadian CMDCAS; Japanese PAL; Anvisa Australian TGA is preferred.

Other:

This position may require up to 30% domestic & 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.
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.