Job Title: Senior Quality Engineer
Location: Remote
Job Summary:
- Join our Commercial Quality group as a Senior Quality Engineer. In this role, you will provide quality engineering support for the product life cycle management and design control systems in the maintenance of commercialized drug delivery devices, combination products, and non-combination products.
Responsibilities:
- Participate in the implementation of Design controls per FDA CFR 820.30, Corrective and Preventive action projects, and documentation related to the investigation of product complaints
- Ensure that Quality Systems for combination products are appropriate and compliant for commercial activities
- Participate in technical aspects of problem-solving, complaints, and other investigations in relevant design control phases
- Act as a liaison with CPOQ Development
- Provide Quality technical expertise and oversight for combination and non-combination products associated with Combination Product Operations activities
- Contribute to content and review of regulatory submissions and responses to agency inquiries
Skills Required:
- Minimum of 5 years of experience in pharma, biotech, or medical device industries
- Bachelor’s Degree in Engineering or a related field
- Deep understanding of quality processes including change control, design controls, risk assessment and management, and root cause analysis
- Knowledge of combination product regulations and standards
- Quality and device engineering expertise
- Detail-oriented and thorough approach to tasks
About SSi People:
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.
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