at ICU Medical in Lake Forest, Illinois, United States
Job Description
This is a hybrid role and can be based out of San Clemente, CA or Lake Forest, IL. Position Summary Under the general direction of the Sr. Director, Quality Systems, the Senior Manager, Quality Systems – Design Controls and Risk Management; administers, directs, and coordinates deployment for elements of the Quality Management System corporate-wide. The senior manager will work collaboratively with cross-functional groups globally (QA, Operations, Engineering, Supply Chain) to ensure effective adoption of Design Controls and Risk Management process across all functional areas. This position requires a strong tactical decision maker to handle unforeseen issues. This position will lead respective process areas toward regulatory compliance. Requires in-depth knowledge of the Design Controls and Risk Management for medical devices, business strategies and the company’s goals. Essential Duties & Responsibilities * Ensure ICU Medical maintains their QA systems in accordance with global procedures. * Support interface/liaison with all Regulatory functions both internal and external agencies such as FDA and notified bodies as needed. Work with Internal Audit function to assure site preparedness for regulatory and notified body visits. * Ensure the interpretation and integration of applicable regulations and standards in the requirements including, ISO 13485, 21 CFR part 820, MDR 2017/745, MDD 93/42/EEC, ISO 14971. * Define and ensure ICU Medical compliance to Global Regulatory requirements and Standards in applicable Procedures * Work with the specific subsystem elements to assure deployment of the systems. * Ownership and optimization of the Design Controls and Risk Management processes. * Collaborate with Design, Development and project stakeholders to provide quality technical support and facilitate the successful execution of the Design Control and Risk Management Process. * Oversee the Risk Management process governance – Identification and management of risk throughout the development process and sustaining efforts with the appropriate definition and use hazard and hazardous situation analysis, harm, risk policy, FMEA, Post Market Surveillance, Risk Management Plans/Reports. * Establish governance of product risk assessment efforts, including and not limited to FMEA, essential performance, software safety classification, risk benefit determination. * Support of QMS Harmonization initiative. * Quality process optimization, especially in the area involving best practices of electronic systems (e.g. Agile) and interaction with Design Controls and Risk Management processes. * Monitor the effectiveness of any and all interim controls put in place during any and all regulatory commitments for the site. * Budget: Responsibility for headcount and other budget responsibility for cost center * Work on special projects as they arise Knowledge, Skills & Qualifications * Minimum 5 years of experience with Design Controls and Risk Management of medical devices is required. * Specific focus on design and maintenance of quality systems to meet regulatory agency expectations and business needs * Detailed understanding of regulatory process and regulations. * Computer literate using Microsoft Word, Excel, PowerPoint, and Visio applications. * Strong technical writing and communication skills. Education and Experience * * Bachelor’s degree in Engineering, Business, or Sciences from an accredited college or university is required * Master’s degree in Engineering, Business, or Sciences from an accredited college or university is preferred * Minimum 10 years related experience in an FDA regulated industry * Minimum 5 years of supervisory experience Salary range: $124k-$166k ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. *Title:* *Senior Manager, Quality – Design Control and Risk Management * *Location:* *IL-Lake Forest Requisition ID: 22301588 Other Locations: US-CA-San Clemente
