Quality Systems Lead — CAPA, Audits & Compliance (Remote)

BioWave Corporation; Westport (CT); On-site; USD 85,000 - 95,000; Full time

Benefits offered by this job

Medical, Vision, Dental Insurance

401K - employer match

Paid time off & holidays

Job summary

BioWave Corporation, a Medtech leader in pain-management solutions, seeks a Quality Systems professional to ensure compliance by developing, implementing, and maintaining the Business Unit's Quality System. You will handle document control, training, CAPA, NCMR, and risk management in a fast-paced environment.

Responsibilities include driving closure of CAPAs, supporting eQMS implementations, and maintaining audit readiness with detailed records and evidence.

Qualifications

• Bachelor's degree from four‑year college or university; 1–2 years related experience and/or training; or equivalent combination of education and experience.
• Experience within a Medical Device company or ISO 9001/13485 certified company preferred.
• Fluency in English, strong written and verbal communication.

Responsibilities

• Develop, implement, and maintain the Business Unit’s Quality System.
• Manage document control, training, change management, nonconformances, CAPA, complaints, and Risk Management.
• Support internal and external audit readiness with real-time trackers and objective evidence.
• Lead cross-functional projects to reduce quality issues and improve closure cycles.

Skills

Quality Management

Teamwork

Communication

Ethics

Detail oriented

Education

Bachelor's degree

Tools

Microsoft Applications

Electronic QMS (e.g., Greenlight Guru)

Job description

BioWave Corporation, a Medtech leader in pain-management solutions, seeks a Quality Systems professional to ensure compliance by developing, implementing, and maintaining the Business Unit's Quality System. You will handle document control, training, CAPA, NCMR, and risk management in a fast-paced environment.

Responsibilities include driving closure of CAPAs, supporting eQMS implementations, and maintaining audit readiness with detailed records and evidence.