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Lake Zurich, Illinois, United States
Onsite
Not Available
Develop, implement, and monitor various quality metrics on a local and global level from both a Design Center and Market Unit perspective.
Identify opportunities for continuous improvement and customer satisfaction. Compile and represent data for monthly CAPA Review and Product Review meetings, as well as annual reports.
Guides the conceptualization, development, evaluation, and implementation of new or improved methodologies, processes, and tools for product and/or process changes.
Gather and analyze data for root cause analysis for complaints, CAPA, and/or SCARs. Coordinate and drive efforts to assure CAPAs and associated projects are opened and completed appropriately. Work with
Engineering and Manufacturing to develop and implement corrective actions.
Support Post Market Surveillance through complaint sample evaluations and investigations.
Track, trend, and escalate recurring product issues by analyzing complaint data in the context of field use, complaint severity, recurrence, customer impact, and potential product or patient risk.
Manage or coordinate follow-up activities in response to actionable trends, including escalation for CAPAs, design changes, risk- management activities, including proposals on field corrective actions, or sustaining projects, as applicable.
Serve as the primary Quality Assurance contact for customer communications and/or regulatory inquiries, coordinating timely, accurate, and compliant responses; perform documented risk assessments and analyses to evaluate product quality, patient or user safety, regulatory impact, and the need for escalation or additional corrective action.
Serve as the primary contact for local and global product complaints and SCAR responses, maintaining a comprehensive status summary that covers investigation progress, open actions, responsible functions, documentation, risks, and target completion dates.
Coordinate cross-functional technical investigation activities with Production Units (PUs), R&D, Commercial, Field Service, and other applicable functions to assess complaints, support root-cause determination and issue resolution, maintain visibility and accountability for complaint status, task ownership, dependencies, risks, and delivery timelines, and identify and escalate barriers requiring additional resources, technical or field support, or management action.
Provide quality support for New Product Development. Incorporate knowledge of customer use and product design to predict product effectiveness and anticipate potential failures.
Influence requirements definitions and ensure that reliability, quality, and safety requirements are met.
Mentor and coach Engineering with the development of test protocols and reports.
Act as a subject matter expert in Change Review Board as part of the change control process.
Ensure compliance to regulatory requirements. Uphold quality system. Support internal and external audits.
Advise senior management regarding appropriate actions.
Requirements
The requirements listed below are representative of the knowledge, skill, and /or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• B.S. degree in Science or in Engineering; CQE certification a plus.
• 8+ years’ experience in of Medical Device (21 CFR 820) and/or Drug (21 CFR 210 & 211) related industry. Quality engineering or Product Development experience preferred.
• Experience with Post Market Surveillance a plus.
• Minimum 1 year of leadership/supervisory responsibility.
• Working knowledge of lean manufacturing, Six Sigma, and Project Management principles.
• Understanding and working experience with EN ISO14971, cGMP, QSR, ISO13485, FDA Design Control, document controls, design verification and validation, hazard analysis techniques, and regulatory approval methods.
• Knowledge of quality control process and statistical techniques.
• Understanding of manufacturing processes and techniques.
• Ability to solve unique and complex problems. Strong attention to detail.
• Proficient with Excel (PivotTables, trending, charting).
• Exercises sound judgment without supervision on complex projects. Leads cross functional groups to resolve issues and contribute to area development.
• Excellent verbal and written communication skills.
• Strong interpersonal skills and the ability to work with cross-functional teams.
• Preferred to have relevant Industry Experience.
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
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.