SENIOR SUPPLIER QUALITY ENGINEER

Provide timely business support for the assigned CSS Supplier 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 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

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 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 drives discussion with supplier while consulting 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 followups, 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.

Performs other duties assigned as needed.

A minimum of a bachelor’s degree in Engineering, an 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.

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.

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

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.

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.

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.