New

Sr QA Supplier Specialist (Region North America)

Fresenius Kabi USA, LLC
$80,000-$100,000
life insurance, 401(k)
United States, Illinois, Chicago
May 23, 2025
Job Summary The Sr QA Supplier Specialist is responsible for supporting the company's short and long term goals for maintaining regulatory, ISO, and global compliance. Assures supplier management and internal audit processes are executed and are in compliance to established procedures. This position has no supervisory responsibilities. The experienced Embedded Software Engineer, under minimal supervision participates in designing, coding, documenting, testing and maintenance of real-time embedded software and accessory software products. Plans and executes small projects in compliance with standard operating procedure for medical device software development. Designs software components complete with documentation and automated test suites for inclusion in larger software systems. Applies standard engineering practices to resolve problems of mid to high complexity, contributes to the validation and verification of software products. May assist and mentor less experienced engineers. Salary Range: $80,000-$100,000 Position is eligible to participate in a bonus plan with a target of 6% of the base salary (include only if applicable to the grade level) Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here. Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (i.e., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum. Responsibilities Facilitates activities associated with supplier management program and supports qualification of new and existing suppliers Collaborates with cross-functional groups to complete supplier (re)qualification activities Interfaces with suppliers for audits (on-site, virtual, hybrid, or document) and requests (re)qualification documentation Performs supplier (re)qualification audit Collects and reviews supplier (re)qualification documentation Prepares supplier (re)qualification reports or assessment/evaluation reports Updates and maintains regional (US QA Compliance) supplier tracking databases Updates global supplier tracking databases Assists team members with supplier qualification activities as needed Supports local, regional, and global departments with their questions/requests relating to suppliers Manages and maintains Approved Vendor List Facilitates activities associated with Regional internal audit program Assure internal audits are scheduled, conducted, and closed Participates in internal audit as a Lead or Co-auditor Plans, prepares, and conducts internal audit Collaborates as Lead or Co-auditor with other auditors (Lead or Co-auditor) to draft audit report, review CAPA Plan, and issue audit closure Interface with auditees Updates and maintains internal audit tracking database Facilitates activities associated with Quality Agreement Executes or supports supplier quality agreement according to defined business relationship with suppliers Executes or supports inter-company quality agreement according to defined business relationship with other non-FK USA entities Collaborates with cross-functional groups and/or suppliers to draft, review, and/or finalize quality agreement Performs periodic review of executed quality agreements and execute action(s) based on the review outcome Updates and maintains regional (US QA Compliance) Quality Agreement database Updates global Quality Agreement database Assist with preparing monthly management review presentation Prepares monthly supplier data for product APQR as requested from Production Units Assists team members in supporting internal, external, customer, and regulatory inspection, as needed Supports maintenance or process improvement of programs for supplier management, internal audit, and quality agreement, as needed Additional tasks as needed Requirements* * Must have a Bachelor's degree in the sciences with 5+ years of progressive challenging QA/QC experience in pharmaceutical or related regulated industry. * Must have an in depth knowledge of current GMP and related quality systems. * Must possess strong communication, interpersonal skills, negotiation and problem resolution skills. * Must be organized, detailed and have ability to handle multiple tasks at once and redirect focus based on company's needs. Must be able to function independently with minimal supervision. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.