USA - Quality Assurance Engineer I- CTQ

Della Infotech, Inc.; City of Syracuse (NY); On-site; USD 60,000 - 90,000; Full time

Job summary

A leading company in the medical device sector seeks a Quality Assurance Engineer to oversee Quality System activities, manage the CAPA program, and ensure compliance with regulatory standards. Ideal candidates will possess a relevant degree and experience in a regulated environment. This position offers the opportunity to engage in impactful quality initiatives while working in a structured manufacturing setting.

Qualifications

• 1-2 years' experience in Quality in a regulated industry.
• Familiarity with 21 CFR compliance preferred.
• Strong ability to interpret regulations.

Responsibilities

• Manage CAPA program and investigations.
• Standardize CAPA processes across sites.
• Analyze and recommend improvements for quality metrics.

Skills

Computer proficiency

Communication skills

Team collaboration

Organizational skills

Education

Associate or BS in business, science, or engineering

Tools

Trackwise

SAP

Microsoft Word

Microsoft Excel

Job description

SUMMARY : This position is responsible for areas of the Quality System. Identify and assess regulatory and quality risk in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.

ESSENTIAL FUNCTIONS : This position manages the project investigations and day-to-day task assignments within the Corrective and Preventive Action (CAPA) program within their assigned site. The position also has responsibility to work closely with various managers at the facility to monitor, manage and maintain metrics for the CAPA program in their specific area. Additionally, this position is responsible for standardizing the CAPA program across different Baxter sites in the Front Line Care (FLC) division. Specific responsibilities may include, but are not limited to :

• Ensures efficient processing of nonconformance management for the Quality Management System in Trackwise.
• Maintain Quality Metrics for NCR / CAPA timeliness and makes recommendations for improvement.
• Leads and facilitate discussions with CAPA owners to drive completion of investigations, root-cause analysis, impact analysis, and closure of events.
• Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Identifies areas for process / quality improvements and supports those efforts.
• Owns and manages several project investigation records at one time.
• Analyze trends to monitor the effectiveness of the CAPA process and drive remediation for improvement
• Follows Good Documentation Practices (GDP) and ensures compliant documentation related to area of responsibility.

QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED

• Must have computer proficiency with solid experience in Microsoft Word, Excel, Trackwise, SAP, and other systems.
• Ability to work effectively as part of a cross functional team.
• Ability to relate and work well with people.
• Excellent organizational, presentation, and verbal / written communication skills.
• Ability to multi-task and work well under pressure.
• Expertise in interpreting regulations and familiarity with GDP and GMP
• Experience with working in an environment subject to compliance with 21 CFR Parts 7, 11, 803, 806, 810, 820 strong preferred.

EDUCATION / EXPERIENCE REQUIRED

• Associate or BS in business, science, or engineering required
• 1-2 years' experience in Quality with a medical device / pharma or other regulated industry. Working knowledge of other medical device regulatory requirements (US, Canada and Europe) highly desirable.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee :

• Must be able to sit for most of the work day.
• Ability to stand or walk for long periods as well.
• Must have good hand to eye coordination and dexterity
• Physical Requirements : Dynamic Lifting capability : Must have the ability to lift 40 pounds at a time.

Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to :

• Wearing a static protective smock at all times while in the work area
• Wearing a ground wrist strap and plugging that wrist strap into the working table.
• Working in close proximity to other employees.
• Working in an environment that is temperature and humidity controlled.

Shift Additional Details Baxter Bill Rate : 42.00Does the position allow for the worker to be virtual / remote? : NoShore Options Available for this Position : Onshore OnlyDirect or Indirect : IndirectKronos Worker? : NoShift : USA-1

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Quality Assurance Engineer • Syracuse, NY, United States