Source Quality Engineer

2 weeks ago

Remote, Oregon, United States Inteldot Full time

Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients Segoe UI in Puerto Rico.

Description:

The Staff Source Quality Engineer (Staff SQE) contractor provides overall quality assurance support in the management of Direct, Indirect Suppliers and/or External Manufacturers engaged in the production of Johnson and Johnson products. He/she leads under minimum supervision the deployment of the Source Quality Management (SQM) strategies and associated standards, policies, procedures, programs, systems, processes, and initiatives for Supply Chain Suppliers.

Responsibilities:

  • Provide timely business support for the assigned 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 srisks andrformance 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, 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.
  • 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 drives discussion with supplier while consulting Source Quality Manager.
  • Develop/execute 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 reviews, 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 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 keeps customer, 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 system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001).
  • Responsible for communicating business related issues or opportunities to next management level.
  • For those who supervise or manage a 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.

Competencies / Skills:

  • 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.
  • Working knowledge of Quality issue investigation, Non-Conformance Reports (NCRs), 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. The 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.

Education:

  • 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 a highly regulated Industry is required.

Compensation and Benefits:

  • Employment (W2) and Professional Services Contract (480) available.
  • Administrative, as per business need.
  • Competitive Pay Rate

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