Senior Supplier Quality Engineer

Johnson & Johnson•Plymouth, MN

1d•Onsite

About The Position

The Senior Supplier Quality Engineer (Sr. SQE) provides overall quality assurance leadership in the management of Direct and 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 CSS franchise. He/she leads the deployment of the Supplier Quality Management (SQM) strategies and associated standards, policies, procedures, programs, systems, processes, and initiatives for suppliers of the CSS 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 about the determination, selection, qualification, monitoring, and disengagement of suppliers. She/he proactively identifies, develops, and leads 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.

Requirements

A minimum of a Bachelor's degree in Engineering, Applied Science, or a related technical and quality field is required.
A minimum of 4 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.
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.
Experience with documentation and technical writing skills, in a regulated compliance environment, is required.
Demonstrated ability to identify compliance risks and assess business impact, is required.
Ability to manage complexity and work in a diverse team environment is essential.
Ability to deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches.
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) required.
The ability to collaborate with all levels of management in a cross-functional team environment is required.
Ability to communicate effectively in English.

Nice To Haves

Working experience in a good manufacturing practice-regulated environment is preferred (medical device, pharmaceutical, etc.).
Demonstrated knowledge of manufacturing principles practices, and procedures.
Direct experience in plant and/or supplier GMP auditing is preferred.
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 Supplier Quality Management principles are desired.
Working knowledge of Quality issue investigation, Non-Conformance Reports (NCRs), and Corrective and Preventative Actions (CAPAs) preferred.
ASQ Certifications for Certified Quality Engineer (CQE), Quality Manager (CQM), and/or Supplier Quality Professional (CSQP) preferred.
Quality Auditor qualifications or Lead Auditor certifications such as ASQ Certified Quality Auditor (CQA) or Biomedical Auditor (CBA) preferred.
Flawless Project Execution (FPX) or Project Management Professional (PMP) trained and certified preferred.
Six Sigma Black Belt/ Green Belt (CSSBB)/CSSGB) or Lean certification from a recognized program or PE leadership training 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.
Must have strong business acumen.

Responsibilities

Provide timely business support for the assigned CSS Supplier Quality Management (SQM) function globally.
Lead, develop, and implement supplier/purchasing controls and associated activities.
Participate in and/or support the identification, selection, qualification, monitoring, and disengagement of suppliers for Supplier Quality Management. May lead this process under the guidance of Supplier 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.
Implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and support material/supplier qualifications.
Own, drive, and lead the assigned Supplier Quality related projects, activities, and initiatives with limited supervision.
Utilize Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for SQM projects.
Utilize analytical and problem-solving skills to develop and optimize supplier performance working in conjunction with the Worldwide Supplier Quality Management Team.
Analyze quality data and identify trends impacting risk benefits requirements of product and quality systems for external suppliers. Actively participates in 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 the Supplier Quality Manager and/or management representative.
Develop/execute Quality Risk Management process for supplier-related matters with partnerships of subject-matter experts.
Own and lead the Supplier 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.).
Leads and drives the closure of Supplier Non-conformances, CAPAs and failure investigations.
Understand or anticipate the customer’s needs and adds value 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 keep customers, management, and appropriate parties apprised.
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.
Comply with all applicable quality management systems, 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 manage 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.
Performs other duties assigned as needed

Benefits

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.