A minimum of a Bachelor's degree is required, preferably in an Engineering, Life Science, or related discipline. FDA and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge required. Candidate should possess excellent communication and inter-personal skills. Candidates should be self-motivated and extremely proactive Candidate must be flexible to accommodate additional effort needed to meet project and organizational deadlines The candidate will be responsible for the following – Provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes. Supplier Development including Robust process implementation and Inspection Readiness. Change control management and qualification of supplier process changes and supplier transfers programs. Supplier Process validation and approval in line with internal and Regulatory requirements. Utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), and international organization for standardization (ISO). Promote continuous improvement and Process Excellence activities within the Global Supply Chain. Resolve problems & eliminate constraints to ensure project and supply targets are met. Work with the Sourcing teams to ensure the supply base is optimized to reflect the most efficient processes; Identify requirement to transfer identified products to alternate supplier or obsolete product. Execute product equivalency assessments. Lead PVE with responsibility for associated documentation. Escalate timeline risk with mitigation recommendations. Collaboration with internal cross-functional team members and suppliers on timeline execution for SQE responsibilities. Liaise with internal stakeholders to ensure any supplier-based decisions are understood and accepted at site level. Connect – Interface with partners in Source, R&D Engineering, Manufacturing Engineering, Receiving Inspection, Manufacturing Quality Engineering, Quality Systems and suppliers serving multiple industries. Shape – Challenge critical thinking skills by solving supplier challenges, such as timely material qualification/maintaining production yield, while simultaneously navigating quality system requirements, engineering best practices, and supply chain demand. Lead – Take accountability for supplier qualification and performance by developing strong relationships with supplier executive leaders to drive improvements throughout the value chain. Deliver – Manage deliverables in a fluid environment with varying levels of complexity while maintaining alignment with multiple stakeholders Perform other duties as assigned. Be responsible for adherence to timelines and ensure milestones are achieved. Capture project specific metrics and present progress reports to Program Management & other stakeholders Report issues to the Customer and TCS management to ensure appropriate closure. Strong experience in a highly regulated industry is required. Relevant experience in the Medical Device industry and/or pharmaceutical industry is required. Six Sigma, Lean, or Lead auditor Certification and trainings an asset. Excellent written and oral communication skills Ability to handle multiple tasks, self-motivate and be detail oriented