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Duties and Responsibilities

· Implements and supports ASP Quality Management System and its integrated programs within the respective region, such as quality systems training, internal audits, nonconformances, corrective and preventive action, records management, field actions, supplier quality management, procurement, servicing, distribution, and post market surveillance.

· Assures compliance with applicable regulations such as, but not limited to, FDA 21 CFR 820, ISO 13485, EU MD Directive/Regulations, China GSP & GMP.

· Maintains, sustains and continuously improves the Quality Management System and monitors the performance and health of the Quality Management System through metrics and analytics.

· Establish local and regional relationships with regulatory affairs, commercial, and logistics team.

· Maintains quality oversight of local distribution and warehouse management process (assessment, qualification, monitoring).

· Maintains quality oversight of any local required establishment licences, or QMS certifications.

· Supports local supplier/vendor selection, qualification, and audits.

· Maintains process for kitting/repack/relabeling activities (if any)

· Ensures timely investigation of nonconformances.

· Establish corrective and preventive actions to mitigate potential or actual noncompliance risks.

· Maintains quality oversight of field service processes/procedures.

· Assesses product quality issues and escalates to upper management through established processes.

· Ensures timely post-market surveillance & vigilance (Field Actions and Product Complaints) management

· Ensures timely and consistent escalation of events.

· Support market quality compliance activities as required by the direct manager and in collaboration with associates.

· Collaborate cross-functionally to support projects assigned by the direct manager.

· Responsible for communicating business related issues or opportunities to next management level.

· Performs other duties assigned as needed.

Qualifications

• Bachelor’s Degree

• Minimum of 5 years of experience in medical device or pharma regulated environment in the areas of Quality, Manufacturing, or related field.

• At least 3 years experience in the Medical Device industry.

  § Demonstrated knowledge of regulatory standards and regulations, such as, but not limited to, FDA 21 CFR 820, EU MD Regulations, China GSP & GMP, ISO 13485, ISO 9001, ISO 14971.

  § Ability to work and communicate in a cross-cultural environment

  § Excellent communication skills both written and verbal

  § Highly developed influence, interpersonal, communication and conflict resolution skills

  § Ability to interact with all levels and disciplines within the organization

  § High sense of urgency, adaptable to meet rapidly changing priorities

  § Proven analytical/quantitative skills

  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 careers.fortive.com (https://stgfortive.taleo.net/enterprise/careers.fortive.com) .

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.