Quality Specialist - Corrections and Removals
Quality Specialist - Corrections and Removals (Randstad Contingent Worker)
This position will be fully remote and can be home-based from anywhere in the US.
In this role, you will have the opportunity to:
Support post market surveillance activities as a Corrections and Removals Quality Specialist for Philips’ Image Guided Therapy Device (PIGT-D) business unit.
You will be responsible for:
• Support the field action process for IGTD including initiation, customer and regulatory notifications, and product correction or removal
• Work with cross-functional team to support development of required documentation of field actions
• Assist with preparation of customer letters, field action status reports, and communications to regulatory agencies and competent authorities for field actions
• Support Issue Impact Assessments (IIAs) and Health Hazard Evaluations (HHEs) to ensure risk assessment and analysis are consistent across products and systems within IGTD.
• Complete activities in alignment with field action strategies.
• Assist with internal communications for correction and removal activities, including communications for senior company management, corporate law, corporate communications, service markets, and distribution partners.
• Maintain electronic records of corrections and removals activities, including consignee lists, communications with regulatory agencies, Field Safety Notice deliveries, receipt of customer responses, status reports, and record closure.
• Continuously tracks field actions and provide ongoing information to teammates as required.
• Reports metrics on the efficacy and efficiency of Corrections and Removals processes.
• Timely submission of Corrections and Removals KPIs for IGTD To succeed in this role, you should have the following skills and experience
To succeed in this role, you should have the following skills and experience:
• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
• Bachelor’s degree in healthcare or science fields
• 2+ years of quality or regulatory experience in the medical device industry
• Strong written and oral communication skills are required
• Ability to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously. Also the ability to work as an individual contributor in a fast-paced, changing environment
• Problem-solving and proficient computer skills are required
• Experience working in a broader enterprise/cross-division business unit model preferred
• Working knowledge of appropriate global medical device regulations, requirements, and standards preferred, such as 21 CFR Parts 803, 806, and 820, ISO13485, European Medical Device Directive (93/42/EEC), European Medical Device Regulation (EU MDR 2017/745 EU) Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, Brazilian Resolution RDC 23, and Therapeutic Goods Act 1989.
• Ability to work in a matrixed and geographically diverse business environment • Multitasks, prioritizes and meets deadlines in timely manner
• Strong organizational and follow-up skills, as well as attention to detail
You will be a part of:
You are empowered to use your voice and expertise to have a positive impact on your team, the business, and health technologies that will improve the health, well-being and care for people around world.
In return, we offer you:
Philips welcomes you to a challenging, innovative environment with great opportunities for you to explore and grow.
Quality is on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, groundbreaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role you will have an array of diverse career opportunities open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
Why work on a project at Philips?
If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you’ll find all that and more with project work at Philips.
The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.