Quality Systems Associate (Remote-Eligible)

BioWave Corporation; Westport (CT); Hybrid; USD 50,000 - 60,000; Full time

Benefits offered by this job

401K plan

Long Term Disability

HSA Accounts

PTO 15–20 days

12 paid public holidays

Remote work environment (East coast)

Job summary

BioWave in Westport, CT is seeking a Quality Systems Associate to support day-to-day administration of the Quality System. This entry-level role handles document control, training records, CAPA, nonconformances, and risk management while helping BioWave maintain compliance and quality objectives.

The role reports to the Sr. Manager Quality Systems and is an on-site position in the BioWave Quality Department, with opportunities to grow in a Medtech environment.

Qualifications

• Bachelor's degree plus approximately two years of related quality systems experience.
• Experience in a medical device company or ISO 9001/13485 environment is preferred.
• Fluency in English; ability to read, write and interpret technical documentation.

Responsibilities

• Maintain quality system records and audit logs (CAPA, nonconformance, documents, training).
• Track CAPA and nonconformance with due dates and ensure records are complete and current.
• Manage document control: formatting, routing, revisions, archival of quality system documents.
• Support internal and external audit readiness by organizing records and follow-up actions.
• Maintain training records and ensure employees complete required quality system training.
• Provide admin and coordination support for quality system improvements and electronic QMS activities.
• Perform other duties as assigned by management.

Skills

Achievement focus

Business Ethics

Communications

Quality Management

Teamwork

Education

Bachelor's degree

Tools

Microsoft Office

Electronic QMS

Job description

BioWave in Westport, CT is seeking a Quality Systems Associate to support day-to-day administration of the Quality System. This entry-level role handles document control, training records, CAPA, nonconformances, and risk management while helping BioWave maintain compliance and quality objectives.

The role reports to the Sr. Manager Quality Systems and is an on-site position in the BioWave Quality Department, with opportunities to grow in a Medtech environment.