What are the responsibilities and job description for the Quality Assurance Specialist position at ZYWIE INC?

QUALITY ASSURANCE (QA) SPECIALIST

DEPARTMENT: Quality Assurance

JOB TYPE: Full-Time

LOCATION: In-Office

REPORTS TO: Quality Assurance Lead Specialist

SUMMARY: Founded in 2014, Zywie is a full-suite, remote cardiac monitoring company specializing in wearable biosensor devices and cloud-based data analytic solutions. Zywie’s flagship product is the ZywieNano™ patch, a small band-aid-like patch that patients wear on their chest to continuously monitor their heart’s electrical activity for up to 30 days. The data collected by the ZywieNano™ patch is sent to Zywie’s cloud-based platform, where it is analyzed by algorithms to provide insights into a patient’s heart rhythm and potential cardiac conditions.

The Quality Assurance (QA) Specialist is responsible for monitoring, inspecting, and proposing measures to correct or improve Zywie’s final products and processes to meet established quality standards. The role ensures that quality requirements are fulfilled consistently throughout production and service delivery.

DUTIES AND RESPONSIBILITIES:

• Develop, implement, and maintain quality assurance protocols and standards.

• Conduct routine and non-routine audits of processes, procedures, and products.

• Identify quality issues and work collaboratively with teams to resolve them.

• Collect and analyze data related to product quality or process performance.

• Prepare reports and documentation on quality metrics, findings, and recommended improvements.

• Ensure compliance with industry regulations, standards, and internal policies.

• Participate in the design and review of test cases, scenarios, and QA procedures (for software or technical roles).

• Provide training to staff on quality assurance processes and tools.

• Act as a liaison between production, operations, and management on quality-related matters.

• Assist in root cause analysis and corrective/preventive action plans (CAPA).

QUALIFICATIONS:

• 2 years of experience in quality assurance or a similar role.

• Strong attention to detail and analytical skills.

• Excellent verbal and written communication skills.

• Proficient in excel.

• Knowledge of quality standards preferred (e.g., ISO 9001, Six Sigma, GMP, etc.).

• Familiarity with regulatory standards relevant to the industry (e.g., FDA, HIPAA, etc.).

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

• Frequent standing, walking, sitting.

• Frequent review, data entry, documentation, analysis, etc. on a computer screen

• Constant verbal communication.

• Occasionally required to lift/push/carry items up to 50 pounds.

BENEFITS:

• Health Insurance

• PTO and Holidays

• 401(K)

• Life Insurance

• AD & D Insurance

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Zywie is an Equal Opportunity Employer. Zywie does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

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