What are the responsibilities and job description for the Quality Assurance Engineer III position at Revvity?
About the Role:
We are seeking a highly skilled and motivated Quality Assurance Engineer to join our team. This role is essential in ensuring product quality and process efficiency by utilizing statistical analysis techniques and quality assurance methodologies. The ideal candidate will provide technical guidance, support validation and equipment qualification programs, and actively contribute to continuous improvement initiatives. If you have a strong background in quality engineering within a regulated environment, we encourage you to apply.
Key Responsibilities:
We are seeking a highly skilled and motivated Quality Assurance Engineer to join our team. This role is essential in ensuring product quality and process efficiency by utilizing statistical analysis techniques and quality assurance methodologies. The ideal candidate will provide technical guidance, support validation and equipment qualification programs, and actively contribute to continuous improvement initiatives. If you have a strong background in quality engineering within a regulated environment, we encourage you to apply.
Key Responsibilities:
- Utilize standard statistical analysis techniques to evaluate process capability.
- Provide technical guidance and training to team members on statistical methods, experimental design, data analysis, and sampling techniques.
- Drive site validation and equipment qualification programs, including the generation, review, and approval of IQ, OQ, PQ protocols and reports.
- Support the CAPA (Corrective and Preventive Action) program by ensuring timely root cause identification for process/product deviations.
- Organize, facilitate, and document Material Review Board activities.
- Collaborate with quality and operations teams to ensure effective corrective and preventive actions.
- Participate in internal and cross-site audit programs.
- Support the Supplier Qualification program and monitor incoming raw material quality.
- Participate in vendor site audits and work with suppliers to improve the quality of delivered products/services and internal processes.
- Work with Quality and Operations management on short- and long-term quality planning and system improvement initiatives.
- Actively participate in site-wide continuous improvement activities.
- Draft new and revise existing Standard Operating Procedures (SOPs).
- Serve as a backup to the QA Manager as needed.
- 3 years of relevant experience in a regulated environment (Pharmaceutical or Medical Devices industry preferred).
- BS/BA degree in Quality Engineering, Biology, Chemistry, Engineering, or a related technical field.
- ASQ Certified Quality Engineer (CQE) certification.
- Experience with Six Sigma and/or Lean methodologies is a plus.
- Strong experience in conducting independent investigations and CAPA identification.
- Experience with Supplier Qualification and complaint handling.
- Proficiency in Internal Auditing.
- Strong ability to work effectively and positively at all organizational levels.
- Capable of working independently and collaboratively; committed to continuous improvement.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Excellent organizational skills and attention to detail.
