Senior Quality Systems Specialist

Senior Quality Systems Specialist

Full Time Headquarter, Westport, CT, US

2 days ago Requisition

Salary Range: $75,000.00 To $80,000.00 Annually

Senior Quality Systems Specialist

Quality Department

Reports to Sr. Manager Quality Systems

19 Newtown Turnpike, Westport, CT 06880

Full-Time, On Site Position

Bio Wave is 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 Wave targets pain at its source to provide long‑lasting results.

Vision & Mission

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.

• 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 escape 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 controls).
• Additional responsibilities as required by management.

• Achievement focus – demonstrates persistence and overcomes obstacles. Measures self against the standard of excellence. Recognizes and acts on opportunities. Sets and achieves challenging goals. Takes calculated risks to accomplish goals.
• Business Ethics – Inspires the trust of others. Keeps commitments. Treats people with respect. Upholds organizational values. Works with integrity and ethically.
• Communications – exhibits good listening and comprehension. Expresses ideas and thoughts in written form. Expresses ideas and thoughts verbally. Keeps others adequately informed. Selects and uses appropriate communication methods.
• Quality Management – fosters quality focus on others. Improves processes, products, and services. Measures key outcomes. Sets clear quality requirements. Solicits and applies customer feedback.
• Teamwork – balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to other views. Gives and welcomes feedback. Puts the success of the team above…