Massachusetts Green Jobs

Staff Supplier Quality Engineer - 2306110186W

Description

Mentor, a Johnson & Johnson Family of Companies member, is currently recruiting for a Staff Supplier Quality Engineer, located in Irving, TX! Remote work options may be considered on a case-by-case basis and if approved by the company.

Mentor is a leading supplier of breast implants in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast surgery patients to improve their quality of life. The company is focused on two strategic areas: breast reconstruction and breast augmentation. MENTOR® is the only manufacturer whose silicone breast implants are made in the U.S.A. For over 20 years, more than 5 million women have chosen MENTOR® Breast Implants.

Job Summary:

The Staff Source Quality Engineer (Staff 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 Staff SQE will be responsible for external suppliers of direct and indirect materials, finished goods, and services for the Ethicon franchise. This position 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 actively demonstrate talents and lead 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 development and execution of plans/strategies, and implementation of systems, processes, and procedures to ensure robust supplier/purchasing controls with regard to the determination, selection, qualification, monitoring, and disengagement of suppliers. Proactively identify, develop, and lead the investigation and resolution of supplier-related challenges, and implements appropriate Quality Engineering methodologies, statistical techniques, process capability analyses/improvements, DOE/process optimization, and other technical or Process Excellence (PEx) tools in support of supplier-related changes, risk management, product/process transfers, innovations, and continuous process enhancements to improve supplier reliability, minimize risks, and ensure sustainable sources of material supply capable of meeting or exceeding Quality, Compliance, and Business requirements.

Key Responsibilities:

Under limited supervision and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• 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 lead the identification, selection, qualification, monitoring, and disengagement of suppliers for Source Quality Management.

• 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.

• Implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and supports material/supplier qualifications.

• Own, drive, and lead the assigned Supplier Quality related projects, activities, and initiatives with limited supervision.

• Apply Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for SQM projects.

• Use analytical and problem-solving skills to develop and optimize supplier performance working in conjunction with the Worldwide Source Quality Management Team.

• Analyze quality data and identify trends impacting risk benefits requirements of product and quality systems for external suppliers. Lead discussions to drive resolution.

• Collaborate with operations and franchise operations development on process/product improvement projects.

• Prepare Supplier Quality Agreements and drive discussion with suppliers while consulting Source Quality Manager.

• Develop/implement a Quality Risk Management process for supplier-related matters with partnerships of subject-matter experts.

• Own and lead the Source Quality Relationship Management (SQRM) process for the assigned suppliers (e.g. Lead periodic SQRM meetings including supplier quality performance evaluations, supplier investigation follow-ups, investigation responsiveness/cycle time, targeted improvement plans (TIP), closed-loop corrective actions, NC reductions, supplier quality metrics, etc.)

• Understand or anticipate the customer’s needs and contributes by providing specific metric information tailored to the particular business environment.

• Take actions to identify internal customer requirements and translate customer requirements into potential proactive improvements to components or supplier quality systems. Proactively pursue clarification to confirm understanding of internal customer needs and requirements. Follow up on commitments and keeps customer, management, and appropriate parties informed.

• Respond proactively to changing regulatory and business needs.

• Lead component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups.

• Apply appropriate Quality Engineering and PEx tools (e.g. PM/VSM, Kaizen, DMAIC, FMEA/FTA, RCA, MSA, SPC, Cp/Cpk/Cpm/Ppk, Hypothesis Testing, ANOVA/DOE/EVOP, etc.) to support innovations and continuous improvements.

• Follow all applicable quality management systems, and environmental, safety, and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001).

• Responsible for communicating business-related issues or opportunities to the next management level.

• For those who supervise or lead staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety, and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.

• Responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.

Qualifications

Education:

• Bachelor's degree in Engineering, Applied Science, or a related technology and quality field is required.

Required Qualifications:

• 6 years of experience in Quality Engineering or Quality Assurance, including data analysis, risk assessment, and risk mitigation.

• Medical Device Directive (MDD), ISO 9001, ISO 13485, ISO 14971, or other international standards).

• Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA systems and investigations, laboratory controls, and production and process controls.

• Experience with documentation and technical writing skills, in a regulated compliance environment.

• Demonstrated ability to identify compliance risks and assess business impact.

• The capability to handle complexity and lead a diverse team is crucial.

• Must have strong discernment. The ability to collaborate with all levels of management in a multi-functional team environment.

Preferred Qualifications:

• Knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs).

• Flawless Project Execution (FPX) or Project Management Professional (PMP) trained and certified.

• Six Sigma Black Belt/ Green Belt (CSSBB)/CSSGB) or Lean certification from a recognized program or PE leadership training.

• Strong analytical skills, metrics development, and the ability to identify trends.

• Knowledge of specific business practices and software applications skills (Word®, Excel®, PowerPoint®, Minitab®, Visio®, and Microsoft Project®).

• Knowledge of Quality issue investigation, Non-Conformance Reports (NCRs), and Corrective and Preventative Actions (CAPAs).

• ASQ Certifications for Certified Quality Engineer (CQE), Quality Manager (CQM), and Supplier Quality Professional (CSQP).

• Quality Auditor qualifications or Lead Auditor certifications such as ASQ Certified Quality Auditor (CQA) or Biomedical Auditor (CBA).

• Component Qualification/Process Validation experience. New product introduction experience.

• Knowledge of manufacturing principles and practices, and procedures.

• Direct experience in plant and/or supplier GMP auditing.

• Ability to deal with complex issues using deductive reasoning, critical analysis skills, and systematic approaches.

• Prior experience with FDA inspections.

• Broad knowledge of Quality System Regulations and Source Quality Management principles.

• Prior manufacturing, plant, or technical background is required. Working experience in good manufacturing practice-regulated environment (medical device, pharmaceutical, etc.).

Other:

• Ability to communicate effectively in English.

• Bilingual in English and another language (Spanish, Dutch, German, Portuguese, or Mandarin) is preferred.

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. 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 .

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.

Primary Location NA-US-Texas-Irving

Other Locations NA-United States

Organization Mentor Texas LP (6182)

Travel Yes, 25 % of the Time

Job Function Quality (Eng)

Req ID: 2306110186W