Sr Customer Quality Specialist - Irvine, United States - Fortive

Description

This position is responsible enhancing customer satisfaction for all customers of Advanced Sterilization Products. The responsibilities include support of the global complaint handling process through completion of reportability determinations, medical reviews, and justifications as well as timely evaluation, investigation and closure of reportable and non-reportable product complaints in accordance with established company procedures and worldwide regulations and standards. The role requires approval of complaint investigations, MedWatch Reports, and advancing trends and product problems.

Responsibilities:

Under general direction and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:

• Authors Clear, Technical, and Accurate Reports Describing Complaints and Investigations for Compliance Files Reviews Incoming Complaints and Completes Good-Faith Effort to Collect Additional Information as Required.
• Independently Completes High Complexity Complaint Investigations within Required Timelines (e.g. Complaints involving Biological Indicators and Chemical Consumables).
• Performs visual or functional testing of returned product as required.
• Initiates Issue Escalation Process as Required.
• Investigates and Documents Complaint Trend Analyses.
• Initiates and investigates through Company CAPA and Non-Conformance Processes as Required.
• Coordinates and Contributes to Customer Response Letters.
• Reviews and Approves Investigations.
• Trains More Junior Associates in Company Complaint Handling Processes.
• Coordinates Efforts with ASP Legal Department for Complaints Regarding Litigation.
• Independently Completes Reportability Determination for US Medical Device Reports (MDRs).
• Completes Medical Device Reports (MDRs) to align with Government Reporting Requirements.
• Provides Input on MDR Guidelines for Reportability.
• Coordinates Medical Reviews and Justifications.
• Coordinates Improvement Initiatives.
• Coordinates and Contributes to Document Change Orders.
• Completes Detailed Gap Assessments to Internal Standards.
• Supports Internal Audits of Complaint Handling Department.
• Maintains Compliance to Applicable Foreign and Domestic Regulations Governing the Management and Processing of Medical Device Related Complaints including Protected Health Information (PHI) and Patient Privacy Laws.
• Responsible for communicating business related issues or opportunities to next management level.
• Performs other duties assigned as needed.

Our Needs:

• A bachelor's degree preferred in Science or Engineering with 4-6 years of experience.
• 2-4 years in the Medical Device Industry OR
• 4-6 years in related regulated industries.
• · Advanced critical thinking and investigation skills are required.
• Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required.
• Effectively prioritize and manage multiple activities and responsibilities.
• Ability to understand and follow complex written procedures is required. Candidates should be familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), nonconformance (NC) and document change control practices.
• Ability to function in a team environment, deliver on team objectives, and inspire change.
• Project management and/or process mapping experience.
• Communication Skills: Strong written and verbal communication skills. Must be highly proficient in reading, writing, and speaking the English language. Prefer developed presentation skills.
• Professional demeanor on the phone and in email is required. Technical writing is a routine part of this position. Strong attention to detail is required.
• Required Computer Skills: Familiarity with computers and Windows-based PC applications. Ability to learn and manipulate complex computer system applications is required. Ability to type at least 50 words per minute (WPM) is required. Experience with word processor software (e.g. Microsoft Word) and internet browsers (e.g. Internet Explorer) is required. Prefer experience with Complaint Management System.
• Working knowledge of sterilization and/or high-level disinfection technologies.

Fortive Corporation Overview

Fortive's essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We're a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.

We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.

At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.

At Fortive, we believe in growth. We're honest about what's working and what isn't, and we never stop improving and innovating.

Fortive: For you, for us, for growth.

Ready to move your career forward? Find out more at

Come join our team at Advanced Sterilization Products (ASP) and be part of a global leader in infection prevention solutions for the healthcare industry. With advanced products, technologies, and workflows for medical sterilization and disinfection, ASP is dedicated to defending the lives of patients, families, healthcare workers, providers, and communities. Add your talent to our extraordinary team and help us in our mission to make healthcare safer for everyone. ASP is based in Irvine, California with core sites in Everett, Washington and Schaffhausen, Switzerland plus many more offices around the world.

We Are an Equal Opportunity Employer

Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should ask to speak with a Human Resources representative to request an accommodation.

Irvine, CA: The salary range for this position is $91,655 - $170,085

This position is also eligible for bonus as part of the total compensation package.

Base pay offered may vary depending on various factors, including, but not limited to: job-related knowledge; skills; experience; and other eligibility factors such as geographic location. The Total Rewards package includes competitive base pay and an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and several programs that provide for both paid and unpaid time away from work.