Revvity, Inc.
Senior Quality Systems Specialist
Revvity, Inc., Mountain Lakes, New Jersey, us, 07046
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.
#LI-TE
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.
#LI-TE