Responsibilities :
- Perform quality activities related to the IVD development activities which includes providing guidance for design controls, risk management, change control, and decisions on product development activities to ensure continued compliance with internal procedures and applicable regulations.
- Provide guidance on stability testing, sample plan definition, process validation study, and design transfer documentation to ensure compliance.
- Ensure required documentation is completed prior to product transfers and product launches.
- Provide guidance on cross-functional teams responsible for implementation of new products, process improvements, and troubleshooting activities.
- Facilitate risk management and change control activities.
- Support processes such as document control, training, CAPAs, and developing quality metrics.
- Identify opportunities for continual improvement and works with management and team members to successfully address these opportunities.
- Develop and maintain organized records that demonstrate compliance to all company processes, regulations, and the company's QMS.
- Perform and document internal audits and make recommendations for corrective actions.
- Perform other related duties and responsibilities as assigned.
- Report and document all concerns of test quality and / or safety to the Supervisor or Safety Officer, as applicable.
Requirements :
- Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific discipline.
- years of quality experience in an FDA / ISO regulated environment.
- Experience in molecular biology products or molecular diagnostic products.
- Knowledge of applying statistical analysis for testing, process control, and design of experiments.
- Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments.
- Ability to work effectively in a team environment and build strong working relationships.
- Ability to successfully balance and prioritize multiple ongoing projects and tasks in a fast-paced, deadline driven environment.
- Excellent problem-solving and analytical skills.
- Effective communication and interpersonal skills.
- ASQ CQE certification is preferred.
- May be required to lift routine office supplies and use office equipment.
- The majority of the work is performed in a desk / office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment.
- Ability to sit for extended periods of time.
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