Responsible for ensuring design quality and regulatory compliance throughout the medical-device product development lifecycle, from concept and design through verification, validation, release, and post-market activities. Leads design controls, risk management, quality reviews, CAPA, change control, and verification/validation activities while partnering with Engineering, Regulatory, Manufacturing, and other cross-functional teams to deliver safe, effective, and compliant products. Current medical-device postings emphasize design controls, ISO 13485, ISO 14971, FDA requirements, and V&V.
- High school diploma or equivalent. Zero (0) to one (1) year warehouse experience or related experience and/or training.
- Obtains and/or maintains appropriate licenses / training / certifications, as needed.
- Has basic skills training in an analytical / scientific method or operational process area (e.g., material handling and management, logistics, manufacturing production).
- Effective communication skills at a level co-workers and Team Lead/Supervisor can understand.
- Ability to read, write, interpret and comprehend documents written in English and perform basic math calculations. Ability to perform/operate in a metrics-driven environment.
- General computer skills.
- Must be able to work Monday - Thursday, 8pm- 6:30am. Uses a variety of equipment such as forklifts, conveyers, cranes, handcarts, and power trucks to move materials, parts, assemblies and finished products or goods within a plant, office or warehouse.
- May maintain records.
- Develops skills in basic tasks, techniques and procedures within one skill area / process / method.
- Applies basic knowledge and skills to complete routine tasks consisting of prescribed steps.
- Works within clearly defined SOPs and / or scientific methods and adheres to quality guidelines.
- Works under general to limited supervision.