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) Supervisor is responsible for overseeing the QA department by monitoring, inspecting, and proposing measures to correct and/or improve Zywie’s final products and processes to meet quality standards. This role will take a lead position with the development, implementation and adherence to quality management systems (QMS) and implemented throughout production and logistics. Effectively coach and mentor quality personnel, establish clear goals, provide constructive feedback, and create a supportive environment. Encourage open communication and active listening. Offer tailored training opportunities, share relevant experiences, and celebrate achievements. Regularly assess progress and adapt strategies to meet organizational/individual needs, while fostering a culture of continuous improvement and professional growth.

DUTIES AND RESPONSIBILITIES:

· Develop, implement, and maintain quality assurance protocols, procedures, and standards.

· Develop, implement, and train on all quality processes, procedures and tools.

· Conduct audits of processes, procedures, and products.

· Responsible for overseeing all quality activities, processes, and personnel.

· Hands-on approach for coaching & mentoring quality personnel for further development.

· Identify quality issues and work cross functionally and collaboratively with teams for resolution.

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

· Prepare reports and documentation on quality metrics (KPI’s), findings, and recommended process 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).

· Act as a liaison between operations/logistics, IT, and management on quality-related matters.

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

· Perform other related duties as assigned.

QUALIFICATIONS:

· 3-5 years of experience in supervisory or leadership experience, with proven ability to coach and mentor QA personnel

· 2+ years of experience in quality assurance or similar role, preferably in a medical device, life sciences, or healthcare technology environment

· ASQ certification or Six Sigman Yellow/Green Belt is a plus

· Experience with quality tools and platforms (e.g. Mastercontrol, Greenlight Guru, Jira, etc.)

· Strong organizational, problem-solving, attention to detail, and analytical skills

· Excellent written and oral communication skills

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

· Familiarity with regulatory standards relevant to the industry (e.g., FDA, HIPAA, etc.) Working knowledge of 21 CFR Part 820, ISO 13485 and/or ISO 14971 preferred

· Proven ability to initiate and drive change

· Commitment to excellence and high standards

· Proficiency in Microsoft Office

· Ability to work with minimal supervision

· Ability to manage priorities and workflow

· Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm

· Proven ability to handle multiple projects and meet deadlines

COMPETENCIES:

· Quality Management--Looks for ways to improve and promote quality; Demonstrates accuracy, thoroughness, and attention to detail.

· Safety and Security--Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.

· Attendance/Punctuality--Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.

· Teamwork--Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.

· Analytical--Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures as needed.

· Problem Solving--Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.

· Adaptability – Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.

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 Company 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.