What are the responsibilities and job description for the Quality Engineer position at SSi People?
Job Title: Quality Engineer - CAPA
Location: Pittsburgh, PA
Job Description:
As a Quality Engineer specializing in Corrective and Preventive Actions (CAPA), you will be the go-to expert for all CAPA-related matters. You will be responsible for reviewing, advising, and facilitating CAPA investigations, ensuring effective solutions and monitoring their effectiveness.
Key Responsibilities:
- Review and advise on product and process CAPAs at various stages of the workflow
- Lead CAPA investigations from issue identification to solution implementation and monitoring
- Update business processes related to CAPA
- Perform detailed CAPA engineering tasks, including issue assessment, data review, and root cause analysis
- Manage all aspects of CAPA projects, including resource allocation, scheduling, and deliverable tracking
- Represent CAPAs during audits and review board meetings, and prepare other spokespersons for the same
Skills Required:
- Bachelor’s degree in engineering or science-related field, or equivalent technical experience in a medical device environment
- Minimum of 10 years of practical experience with CAPA
- Ability to understand and analyze complex problems, including software and hardware design issues
- Knowledge of root cause analysis tools and techniques
- Familiarity with global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971
- Strong project management skills and ability to manage all CAPA activities
- Excellent reasoning, logical thinking, and communication skills in English.
About SSi: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
Salary : $52 - $55
