Lead Quality Systems Engineer

2 weeks ago

Reno, Nevada, United States Revvity Full time

Employer: Revvity
Position: Senior Quality Systems Specialist
Work Schedule: Monday through Friday, 40 hours/week

Revvity is a prominent player in the medical diagnostics sector, committed to enhancing diagnostic science and improving lives globally. With a diverse range of products and cutting-edge technologies, we strive to deliver swift, precise, and dependable diagnostic solutions. Our dedicated workforce of over 3,300 professionals across 17 countries develops, manufactures, and markets test systems that aid in disease diagnosis, alongside software and automation solutions for testing performance and evaluation. Our assays and automation are utilized in laboratories across more than 140 countries for various testing needs, including autoimmune, infectious diseases, allergies, antigens, and molecular diagnostics. Revvity is proud to foster a people-centric culture, earning recognition as one of New Jersey's top workplaces.

We are currently seeking a Senior Quality Systems Specialist to play a pivotal role in our Quality Management (QM) department. This individual will spearhead the development and enhancement of our quality management system. The Senior Quality Systems Specialist will be responsible for training staff on QM processes and providing expert guidance to team members. This role involves overseeing and contributing to assigned QM processes and engaging in continuous improvement initiatives. Effective communication across all departments is essential to ensure compliance with Quality Systems requirements.

The Senior Quality Systems Specialist will report directly to the Quality Systems Manager.

KEY RESPONSIBILITIES

  • Ensure adherence to all company policies, procedures, and compliance with safety and regulatory standards.
  • Assist in the upkeep of the company's Quality Management System.
  • Maintain a thorough understanding of applicable regulations, including ISO 13485 and 21 CFR Part 820.
  • Lead QM training initiatives, including organizing training events, preparing materials, conducting sessions, and maintaining training records.
  • Participate in internal quality audits, prepare audit reports, and initiate CAPA or other necessary actions.
  • Actively engage in external quality system audits, including pre-work and post-audit responsibilities.
  • Manage processes for handling non-conforming and returned products.
  • Ensure rework processes are conducted according to established procedures and documentation.
  • Provide expertise and leadership in addressing non-conformances and CAPA Action Plans.
  • Implement risk mitigation strategies through various control and risk management activities.
  • Collaborate with departments such as Production, Quality Control, Technical Support, and IT to ensure compliance with cGMP, sampling, qualification, statistical process control analysis, software qualification, and other business-related activities.
  • Oversee supplier management activities to guarantee quality products are procured and utilized within the quality system.
  • Assist in preparing necessary documentation to maintain compliance.
  • Monitor and evaluate metrics, presenting relevant data to 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 a Life Sciences discipline.
  • 5 years of experience in Quality Systems within the Medical Device or Clinical Laboratory field.
  • Proficiency in ISO 13485 and 21 CFR Part 820.
  • Experience leading external and internal audits.
  • Expertise in CAPA resolution.
  • Skilled in writing technical documentation.

PREFERRED QUALIFICATIONS

  • Familiarity with MDSAP Audit Approach.
  • Experience in Process Risk Assessment.
  • Knowledge of Lean and Six Sigma methodologies.
  • Strong attention to detail with the ability to draft SOPs and other technical documents.
  • Deadline-oriented work ethic with the capacity to manage varying priorities.
  • Highly organized, capable of working efficiently and independently with minimal supervision.
  • Proactive planner with strong critical thinking skills.
  • Excellent verbal and written communication abilities.
  • Positive demeanor with a proactive attitude.
  • Proficient in computer applications (MS Word, Excel, Outlook, etc.).

WHAT DO WE OFFER?

We provide a competitive and comprehensive benefits package for our employees. Some highlights include:

* 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

PDN-9a854c7b-645d-4723-bf5d-d3b8fe5a57a2

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