Innovative Quality Systems Expert

3 weeks ago

Reno, Nevada, United States Revvity Full time

At Revvity, a leading manufacturer of medical laboratory diagnostics, we are seeking an experienced Senior Quality Systems Specialist to join our Quality Management team.

As a key member of our QM department, you will play a vital role in developing and implementing our quality management system, ensuring compliance with regulatory requirements and company policies.

The ideal candidate will have a strong background in quality systems, preferably in the medical device or clinical laboratory industry. A bachelor's degree in a life sciences discipline and at least 5 years of experience in quality systems are required.

You will be responsible for maintaining our quality management system, providing training to employees, and participating in internal and external audits. Additionally, you will oversee processes for handling non-conforming products, returned products, and rework, as well as provide expertise and guidance to other team members.

A strong understanding of ISO 13485 and 21 CFR Part 820 is essential, and experience leading external and internal audits, as well as CAPA resolution expertise, is highly desirable.

You will work closely with other departments, such as Production, Quality Control, Technical Support, and IT, to ensure compliance with cGMP, sampling, qualification, statistical process control analysis, software qualification, transfer of production, and other activities related to the scope of the business.

We offer a competitive salary range of $95,000 - $120,000 per year, depending on experience, as well as a comprehensive benefits package, including medical, dental, and vision insurance, life and disability insurance, paid time-off, parental benefits, 401k with company match, and an employee stock purchase plan.

Located in Mountain Lakes, NJ, this role offers the opportunity to work with a dynamic team and contribute to the development of our quality management system.

We are committed to providing a work environment that fosters collaboration, innovation, and growth. If you are a motivated and experienced quality systems professional, we encourage you to apply for this exciting opportunity.

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

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.)

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