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Staff Source Quality Engineer

company-logo

Johnson & Johnson

4.3

Multiple Locations

Why you should apply for a job with Johnson & Johnson:

  • Johnson & Johnson is on Fairygodboss’ Best Companies for Women of 2020.

  • Fairygodboss members gave this company a 4.3/5 in overall job satisfaction

  • Fairygodboss members working at Johnson & Johnson rated their manager’s support a 4.4/5

  • 73%

    Reviewers say women are treated fairly and equally to men

  • 89%

    Reviewers would recommend company to other women

  • 86%

    Reviewers say the CEO supports gender diversity

  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).

  • Global exercise reimbursement.

  • Two weeks off (one of them fully paid) for volunteer work.

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#2206047185W

Position summary

Ethicon Inc., member of the Johnson & Johnson’s Family of Companies, is recruiting for a Staff Source Quality Engineer to be located in ETHICON manufacturing and/or ETHICON office sites in the US, Puerto Rico, Mexico or Brazil. Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. We deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com. The Staff Source Quality Engineer (SQE) provides overall quality assurance leadership in the management of Direct, Indirect Suppliers and/or External Manufacturers engaged in the production of Johnson and Johnson products. The Sr. SQE will be responsible for external suppliers of direct and indirect materials, finished goods and services for the Ethicon franchise. He/she leads the deployment of the Source Quality Management (SQM) strategies and associated standards, policies, procedures, programs, systems, processes, and initiatives for suppliers of the Ethicon supply chain. This individual will leverage talents and coordinate teams (SQEs and others), collaborate with Strategic Sourcing/Procurement, R&D, Engineering/Technical Operations, Quality, Operations, business partners/stakeholders, and external suppliers to implement solutions and improve suppliers’ quality and overall service and performance. In this role, the individual supports the execution of plans/strategies, and implementation of systems, processes, and procedures to ensure robust supplier/purchasing controls with regards to the determination, selection, qualification, monitoring, and disengagement of suppliers. Key Responsibilities Provide timely business support for the assigned Ethicon Source Quality Management (SQM) function globally. Lead, develop, and implement supplier/purchasing controls and associated activities including Approved Supplier List management. Participate in and/or support the identification, selection, qualification, monitoring, and disengagement of suppliers for Source Quality Management. May lead this process under the guidance of Source Quality Manager and/or management representative. Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems. Partner with Procurement, R&D, Engineering/Technical Operations, Quality, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions. Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes. Utilize Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for SQM projects. Own and lead the Source Quality Relationship Management (SQRM) process for the assigned suppliers (e.g. Lead periodic SQRM meetings including supplier quality performance reviews, supplier investigation follow-ups, investigation responsiveness/cycle time, targeted improvement plans (TIP), closed loop corrective actions, NC reductions, supplier quality metrics, etc.). Lead component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups. Qualifications A minimum of a Bachelor's degree in Engineering, an Applied Science or a related technical and quality field is required. A minimum of 6 years of experience in Quality Engineering or Quality Assurance, including data analysis, risk assessment and risk mitigation is required. Prior manufacturing, plant or technical background is required. Working experience in good manufacturing practice regulated environment is preferred (medical device, pharmaceutical, etc.). Demonstrated knowledge of manufacturing principles and practices, and procedures. Direct experience in plant and/or supplier GMP auditing is preferred. Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA systems and investigations, laboratory controls, production and process controls, is required. Ability to manage complexity and lead a diverse team is essential. Ability to deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches. Preferred Knowledge and Skills Component Qualification/Process Validation experience is preferred. New product introduction experience is desired. Prior experience with FDA inspections is desirable. Broad knowledge of Quality System Regulations and Source Quality Management principles is desired. Working Knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs), Medical Device Directive (MDD), ISO 9001, ISO 13485, ISO 14971 or other international standards) preferred Knowledge of Non-Conformance Reports (NCRs) and Corrective/Preventative Actions (CAPAs) is a plus Process Validation experience is preferred Professional Certifications: ASQ CQE, CSQP, CMQ/OE, CSSGB, CSSBB, CQA, and/or Project Management are preferred Strong analytical skills, metrics development and ability to identify trends are desirable. Knowledge of specific business practices and software applications skills (Word®, Excel®, PowerPoint®, Minitab®, Visio®, Microsoft Project®) is preferred Ability to collaborate with all levels of management in cross-functional team environment is required Ability to communicate effectively in English Bilingual in English and other language (Spanish, German, Portuguese, or Mandarin) is preferred Location and Travel Requirements The primary location of the position to be based at ETHICON manufacturing and/or ETHICON office sites. This position may require up to 25% domestic and international travel. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. 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. Primary Location United States-Georgia-Cornelia-655 Ethicon Circle Other Locations North America-United States-Texas-El Paso, North America-United States-Texas-San Angelo, North America-United States-Puerto Rico-San Lorenzo, Latin America-Mexico-Chihuahua-Juarez, North America-United States-Puerto Rico-Guaynabo, North America-United States-Georgia-Athens, Latin America-Brazil-São Paulo-São José dos Campos Organization Ethicon Endo Surgery, LLC (7597) Job Function Engineering Requisition ID 2206047185W

What are Johnson & Johnson perks and benefits

Child care benefits

Paid maternity

Unpaid maternity

Paid paternity

Unpaid paternity

Paid adoptive

Short term disability

About the company

27666

Johnson & Johnson

Industry: Consumer Packaged Goods: Packaged Products
By caring for the world one person at a time, we aspire to help billions of people live longer, healthier, happier lives. This aspiration inspires and unites the approximately 127,100 employees of Johnson & Johnson across more than 250 operating companies in 60 countries. We embrace research and science, bringing innovative ideas, products and services to advance the health and well-being of people. For 130 years, the Johnson & Johnson Family of Companies has been committed to caring for people around the world.

Why you should apply for a job with Johnson & Johnson:

  • Johnson & Johnson is on Fairygodboss’ Best Companies for Women of 2020.

  • Fairygodboss members gave this company a 4.3/5 in overall job satisfaction

  • Fairygodboss members working at Johnson & Johnson rated their manager’s support a 4.4/5

  • 73%

    Reviewers say women are treated fairly and equally to men

  • 89%

    Reviewers would recommend company to other women

  • 86%

    Reviewers say the CEO supports gender diversity

  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).

  • Global exercise reimbursement.

  • Two weeks off (one of them fully paid) for volunteer work.

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