Senior Source Quality Engineer

Senior Source Quality Engineer

We at Orion Group are currently recruiting a Senior Source Quality Engineer on behalf of one of our Multinational Medical Device Clients in Cork to work on a 12-month contract.

RESPONSIBILITIES:

• Provide overall quality assurance leadership in the management of suppliers engaged in the production of 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 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 an asset.
• This position may require some EU based travel

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.