The Quality Assurance Specialist is responsible for implementation of the company Quality System (QS) in compliance with US FDA regulations, and in alignment with the business needs of the company.
The complex nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multi-task and to be flexible with tasks and schedules, and the ability to work independently in a team environment. The Quality Specialist must exhibit skills such as good judgment, sound analysis and decision making, the ability to remain professional and composed under pressure, effective interpersonal skills, and the ability to effectively communicate to all levels of the Quality department and across departments
- Create, review and approve policies, procedures, work instructions, protocols and reports to assure compliance with regulations including IVD and FDA.
- Ensure that products are released or services are provided in compliance with company procedures.
- Maintain the company Corrective and Preventive Action system (CAPA) for investigating and resolving quality problems.
- Maintain the supplier quality program, including create/maintain quality agreements, perform audits per audit schedule, and ensure supplier corrective actions.
- Perform internal quality system audits per schedule.
- Perform QA activities for validation of products, processes, and equipment.
- Maintenance of the library of external standards which may apply to company and/or company products.
- Support employee training program to ensure effective training and compliance with regulations.
- Maintain systems to ensure resolution of quality issues including CAPA and complaints.
- Maintain metrics for quality systems including; Internal audits, Supplier Quality, CAPA, and complaints.
- Represent the Quality function on various cross functional teams.
- Minimum of 5 years QA experience in medical devices or IVD.
- Bachelor degree in Biological Science or related field
- Working knowledge of local, state, and federal laboratory regulations
- Possess a working knowledge of FDA regulations applicable to company products.
- Strong written and oral communication skills
- Ability to work independently, to analyze and problem solve issues that impact quality.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT :
Travel Requirements: No Travel
- Standing or sitting for long periods of time may be necessary
- Some lifting (greater than 25 pounds) may be necessary; Facilities, Materials and Engineering employees occasionally must lift at least 50-75 pounds.
- May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high speed centrifugation (GENERALLY LABORATORY & CUSTOMER SERVICE EMPLOYEES ONLY)
- Repetitive manual pipetting may be necessary (LAB EMPLOYEES ONLY)
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