Quality Systems Coordinator — MedTech (On-site)

Evolving Solution Services; Westport (CT); On-site; USD 50,000 - 60,000; Full time

Benefits offered by this job

401K match

Life Insurance

Long Term Disability

HSA Accounts

PTO 15–20 days per year

12 paid holidays

Remote work environment East coast hrs

Job summary

BioWave seeks a Quality Systems Associate to support the daily management of our Quality System at our Westport, CT site. This entry-level role emphasizes document control, training records, CAPA, nonconformances, and risk management while maintaining compliance with ISO 9001/13485 standards.

The role reports to the Sr. Manager Quality Systems and requires a Bachelor’s degree with about two years in quality-related fields.

Qualifications

• Bachelor's degree with approximately two years of related quality systems, quality assurance, or regulated industry experience.
• Experience in a medical device company or ISO 9001/13485-regulated environment preferred.
• Working knowledge of/Fluency in the English language (spoken and written).

Responsibilities

• Support the maintenance and day-to-day administration of BioWave’s Quality System.
• Assist CAPA, nonconformance, document control, training, and audit tracking logs.
• Help ensure records are complete and current and contribute to audit readiness.
• Maintain training records and support quality system improvements and electronic QMS activities.

Skills

Achievement focus

Business Ethics

Communications

Quality Management

Teamwork

Education

Bachelor's degree

Tools

Microsoft Office

QMS software

Job description

BioWave seeks a Quality Systems Associate to support the daily management of our Quality System at our Westport, CT site. This entry-level role emphasizes document control, training records, CAPA, nonconformances, and risk management while maintaining compliance with ISO 9001/13485 standards.

The role reports to the Sr. Manager Quality Systems and requires a Bachelor’s degree with about two years in quality-related fields.