Senior Quality Systems Specialist

Bio Waveis a Medtech company redefining pain management through our innovative, non-invasive technology that delivers powerful relief without drugs or surgery. We offer a range of products designed to meet the unique needs of different markets, delivering effective, customized pain relief solutions where they’re needed most. Our technology is backed by clinical evidence and real-world results, helping patients reduce pain, restore function, and reclaim their lives.

Trusted by healthcare professionals, athletes, veterans, and individuals alike, Bio Wavetargets pain at its source to provide long-lasting results.

Reports to Sr. Manager Quality Systems

19 Newtown Turnpike, Westport, CT 06880

Full-Time, On Site Position

Bio Waveis a Medtech company redefining pain management through our innovative, non-invasive technology that delivers powerful relief without drugs or surgery. We offer a range of products designed to meet the unique needs of different markets, delivering effective, customized pain relief solutions where they’re needed most. Our technology is backed by clinical evidence and real-world results, helping patients reduce pain, restore function, and reclaim their lives.

Trusted by healthcare professionals, athletes, veterans, and individuals alike, Bio Wavetargets pain at its source to provide long-lasting results.

Our Vision is to transform pain management by solving complex pain conditions with innovative, patented, drug-free technology and patient-first, collaborative support - empowering clinicians to deliver better outcomes and enabling people to reclaim their lives with less pain and more possibility.

Our Mission is to help people win their battle with severe pain.

To ensure compliance through the development, implementation, and maintenance of the Business Unit’s Quality System. This includes electronic and paper-based methods for document control, training, change management, nonconformances, CAPA, complaints, and Risk Management. Additionally, this position upholds the Quality Objectives and KPIs for Bio Wave .

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform the following satisfactorily (other duties may be assigned). Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Create, maintain, and distribute monthly trending reports and metrics to provide visibility of QMS health (CAPA/NCMR aging, closure performance, audit actions, document control timeliness, and supplier performance), and elevate overdue/high-risk items.
• Execute and drive closure of CAPA actions, nonconformances (NCMRs), and related corrective activities by coordinating owners, tracking due dates, collecting objective evidence, and ensuring records are complete and audit-defensible.
• Support implementation of an electronic QMS (e.g., Greenlight Guru) by migrating legacy records, standardizing workflows, and ensuring CAPA/NCMR/document control processes are consistently executed within the system of record.
• Support internal and external audit readiness by maintaining real-time trackers, assembling objective evidence, supporting responses to audit findings, and confirming closure activities and effectiveness checks are completed on schedule.
• Update, control, and maintain procedures, forms, and records to ensure only current revisions are in use and that training/implementation evidence is captured and retrievable.
• Contribute to and lead cross‑functional projects that reduce recurring quality issues, improve closure cycle times, and strengthen end‑to‑end compliance (document control, change control, CAPA, NCMR, supplier…