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Lead Quality Systems Engineer
2 months ago
Employer: Revvity
Position: Senior Quality Systems Specialist
Work Schedule: Monday through Friday, 40 hours/week
Revvity is a prominent entity in the medical diagnostics sector, recognized for its commitment to innovation and excellence in laboratory diagnostics. With a diverse range of products and cutting-edge technologies, we strive to deliver prompt, precise, and dependable diagnostic solutions. Our dedicated workforce of over 3,300 professionals across 17 countries is engaged in the development, production, and distribution of diagnostic test systems, software, and automation solutions for various medical conditions. Our products are utilized in laboratories worldwide, supporting the diagnosis of autoimmune diseases, infectious diseases, allergies, and more. Revvity is proud to foster a people-oriented culture, earning recognition as one of New Jersey's top workplaces.
We are currently seeking a Senior Quality Systems Specialist to enhance our Quality Management (QM) department. This pivotal role involves spearheading the advancement of our quality management system. The Senior Quality Systems Specialist will provide essential training to staff on QM processes and offer expert guidance to team members. This position requires active participation in overseeing assigned QM processes and engaging in continuous improvement initiatives. Effective communication across all departments is crucial to ensure compliance with quality system requirements.
The Senior Quality Systems Specialist will report directly to the Quality Systems Manager.
KEY RESPONSIBILITIES
- Ensure adherence to company policies, procedures, and all safety and regulatory standards.
- Assist in the upkeep of the organization's Quality Management System.
- Maintain a thorough understanding of relevant 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 reports, and initiate corrective actions as needed.
- Actively engage in external quality system audits, managing pre- and post-audit activities.
- Oversee processes for managing non-conforming and returned products.
- Ensure rework processes are conducted according to established procedures and documented appropriately.
- Provide expertise and leadership in addressing non-conformances and developing 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, and other operational requirements.
- Manage supplier quality control activities to ensure the procurement of quality products.
- Assist in preparing documentation necessary for ongoing compliance.
- Monitor key metrics and present 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.
- Minimum of 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 internal and external 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.
- Ability to manage deadlines and adapt to shifting priorities.
- Highly organized and capable of working independently with minimal supervision.
- Proactive with strong critical thinking skills.
- Excellent verbal and written communication abilities.
- Positive attitude and a strong work ethic.
- Proficient in Microsoft Office Suite (Word, Excel, Outlook, etc.).
WHAT DO WE OFFER?
Revvity provides a competitive and comprehensive benefits package to our employees, including:
- Medical, Dental, and Vision Insurance Options
- Life and Disability Insurance
- Paid Time-Off
- Parental Benefits
- 401k with Company Match
- Employee Stock Purchase Plan
For more information about Revvity's benefits, please visit our Why Revvity page.
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