Quality Assurance Specialist
3 settimane fa
The Quality Assurance Engineer is responsible for ensuring the quality of medical devices and products. This involves daily support of products, processes, materials, and equipment to achieve production goals such as quality, delivery, cost, productivity, and safety.
Key Responsibilities:
- Identify manufacturing process defects by dispositioning non-conforming material, assisting in identification of primary root causes, and understanding corrective and preventative actions.
- Work with process owners to bound product stops and document release criteria.
- Understand product quality plans, documents, and systems by reviewing product specifications, quality specifications, and working with quality systems.
- Learn risk analyses and FMEAs.
- Monitor systems by becoming familiar with systems applications and critical process steps, and through familiarization with methods used to reduce process variation.
- Get involved in various stages of equipment and processes validations, including running, reviewing, and approving reports.
Required Knowledge, Skills, and Abilities:
- In-depth familiarity with ISO, MDD/MDR, FDA, and medical device industry quality requirements associated with product development, design controls, and product risk management.
- Detailed understanding and working knowledge of Medical Device Directive/Medical Device Regulation, EN ISO 13485, EN ISO 14971, IEC 60601, and US regulations 21CFR820.
- Strong communication and presentation skills.
- Competent with use of Microsoft Office Suite and Minitab Statistical Analysis software.
Minimum Required Education and Experience:
- 3-5+ years of medical device or pharmaceutical engineering experience preferred.
- BS in Mechanical, Electrical, Biomedical Engineering, or Pharmaceutical Chemistry.
- MS strongly preferred.
About PhysIOL:
We are a diversified surgical ophthalmic business with a portfolio of trusted brands and a commitment to delivering innovative solutions for physicians and patients. Our purpose is to touch the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye.
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