Employer: EUROIMMUN US, Inc.
Location: 1 Bloomfield Avenue, Mountain Lakes, NJ 07046 (100% onsite)
Hours: Monday through Friday, 40 hours/week
EUROIMMUN US (a Revvity Company) is one of the leading manufacturers of medical laboratory diagnostics worldwide. EUROIMMUN US stands for innovation and is dedicated to improving the science of diagnostics and people's lives worldwide. Our extensive product portfolio and innovative technologies are designed to provide quick, accurate, and reliable diagnoses. More than 3,300 employees in 17 countries develop, produce, and sell test systems to support the diagnosis of diseases, as well as software and automation solutions for the performance and evaluation of these tests. Laboratories in over 140 countries use our assays and automation for autoimmune, infectious disease, allergy, antigen, and molecular testing. EUROIMMUN US proudly prioritizes a people-centered culture, securing a spot among New Jersey's 2023 Top Places to Work.EUROIMMUN US is seeking a Senior Quality Systems Specialist. This person will be a key addition to the Quality Management (QM) department, and in leading the development of the organization’s quality management system. The Senior Quality Systems Specialist will provide training to other employees as necessary on the company’s QM processes, as well as to provide expertise and guidance to other team members. This person will play an active role to oversee and contribute to assigned QM processes, and participate in continuous improvement activities. The Senior Quality Systems Specialist will communicate actively and effectively among all departments and employees, to support and ensure the requirements of the Quality Systems are met.
The Senior Quality Systems Specialist will report to the Quality Systems Manager.
Key Responsibilities

• Adhere to all company policies, procedures, and comply with all safety and regulatory requirements
• Assist in maintenance of the company’s Quality Management System
• Demonstrate understanding and maintain all applicable regulations such as but not limited to ISO 13485 and 21 CFR Part 820
• Take lead role in managing QM training activities such as but not limited to organizing training events, preparing training materials, conducting training sessions, and generating/maintaining training records
• Participate in internal quality audits, prepare audit reports, initiate CAPA or other activities as necessary
• Participate as an active member during external quality system audits, considering pre-work and post-audit activities
• Oversee and control processes for handling non-conforming products, returned products
• Oversee rework (if any) is performed by following appropriate procedures and their documentation
• Provide expertise, guidance, and lead, as applicable, non-conformances and CAPA Action Plans
• Mitigate risks through establishing various control and other risk management activities as appropriate
• Work directly with other departments such as Production, Quality Control, Technical Support, and IT to advise and oversee the requirements for cGMP, sampling, qualification, statistical process control analysis, software qualification, transfer of production, and other activities related to the scope of the business are met on a continuing basis
• Oversee purchasing control activities such as supplier management to ensure quality products are acquired and utilized throughout the quality system
• Assist in preparing all necessary documentation required to ensure continuing compliance
• Monitor and measure metrics and present relevant data to the management

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.Basic Qualifications

• Bachelor’s Degree in Life Sciences discipline
• 5 years of Quality System experience, in Medical Device or Clinical Laboratory
• Must have ISO 13485 and 21 CFR Part 820
• Experience Leading External/Internal Audits
• CAPA resolution expertise
• Experienced at writing Technical Documents

Preferred Qualifications

• Experience with MDSAP Audit Approach
• Experience with Process Risk Assessment
• Experience with Lean and Six Sigma methodologies
• Keen attention to detail, with the ability to write SOPs and other technical documentation
• Deadline driven work ethic, with the ability to work with varying priorities
• Well organized, able to work efficiently and independently with minimum supervision
• Proactive, planning and exhibits high level of critical thinking abilities
• Strong verbal and written communication skills
• Enthusiastic demeanor with a can-do attitude
• Strong computer skills (MS Word, Excel, Outlook etc.)

WHAT DO WE OFFER?
We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits:

• Medical, Dental, and Vision Insurance Options
• Life and Disability Insurance
• Paid Time-Off
• Parental Benefits
• 401k with Company Match
• Employee Stock Purchase Plan

Learn more about Revvity’s benefits by visiting our Why Revvity page.