Initial 12 month contract role
- Provide overall quality assurance leadership in the management of suppliers engaged in the production of company products.
- 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).
- Project management – planning, scheduling, tracking and execution of project activities as part of supplier and part qualification.
- 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
Education, Experience and Skills:
- A minimum of a level 8 bachelor’s degree is required, preferably in an Engineering, Life Science, or related discipline.
- A minimum of 5 years of experience in a highly regulated industry is required.
- Experience in the Medical Device industry and/or pharmaceutical industry is required.
- FDA and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge required.
- Six Sigma, Lean, or Lead auditor Certification and trainings are an asset.
- This position may require some EU based travel