Sr. Source Quality Engineer

• Provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
• Supplier Approval & Qualification.
• Supplier Development including Robust process implementation and Inspection Readiness.
• Change control management and qualification of supplier process changes andsupplier 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;
o Identify requirements for product approvals, transfers or obsolescence.
o Execute product equivalency assessments.
o Lead PVE with responsibility for associated documentation.
o Escalate timeline risk with mitigation recommendations.
o Collaboration with internal cross-functional team members and suppliers on timeline execution for SQE responsibilities.
o Liaise with internal stakeholders to ensure any supplier-based decisions are understood and accepted at site level.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

• 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 isrequired.
• 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.
• Work travel requirements ~ 10%.

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.