QA Specialist II
Global healthcare leader whose portfolio of life-changing technologies spans the spectrum of healthcare. Products range from diagnostic and generic medications to medical devices and beyond.
Sun-Wed or Wed to Sat 8am to 6pm
- Assures the quality of manufactured products and processes per standard operating processes(SOP’S) and GMP (Good Manufacturing Practices).
- Conduct quality-related activities to deliver consistent high quality documents, services, products and processes, which adds value to the business.
- Provides compliant solutions to a variety of problems of moderate scope and complexity.
- Complaint Evaluation – Investigates complex complaints with management oversight.
- Design Control / Documentation & Change Control – Identifies areas for process improvement.
- Quality Engineering – Coordinates quality decisions between different quality and engineering groups.
- Participates in the development or modification of validation packages, design plans, and risk management deliverables.
- Team member helping and interfacing with suppliers to deliver product meeting our quality requirements (e.g. FMEAs).
- Ensures compliant documentation, carrying out tasks related to area of responsibility with management oversight.
Bachelor’s Degree in Life Science, Engineering, or closely related discipline or an equivalent combination of education and work experience.
- 3 years of work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
- Demonstrates technical and business competencies that drive results and continuous improvement.
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!