Senior Quality Systems Specialist

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

About BioWave

BioWaveis 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, BioWavetargets pain at its source to provide long-lasting results.

Quality Department

Reports to Sr. Manager Quality Systems

19 Newtown Turnpike, Westport, CT 06880

Full-Time, On Site Position

About BioWave

BioWaveis 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, BioWavetargets 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.

Job Description

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 BioWave .

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 controls).
• Additional responsibilities as required by management.

Competencies

To perform the job successfully, an individual should demonstrate the following competencies.

• 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 listing and comprehension. Expresses ideas and thoughts in written form. Expresses ideas and thoughts verbally. Keeps others adequately informed. Select and use appropriate communication methods.
• Quality Management – Foster’s 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 one's own interests.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience

Bachelor's degree from four‑year college or university; or one to two 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.

Language Ability

Read, analyze and interpret scientific and technical journals, financial reports and legal documents. Respond to inquiries or complaints from customers, agencies or members of the business community. Write speeches and articles for publication. Working knowledge of/Fluency in the English language (spoken and written).

Mathematical Ability

Apply advanced concepts such as exponents, logarithms, quadratic equations and permutations. Apply operations to such tasks as frequency distribution, test reliability/validity, variance analysis, correlation technique, sampling theory and factor analysis.

Reasoning Ability

Define problems, collect data, establish facts and draw valid conclusions. Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills

To perform this job successfully, an individual should have knowledge of

• Intermediate to expert level use of Microsoft Applications (e.g., Word, Excel, PowerPoint, Outlook)
• Experience with electronic Quality Management Systems preferred

Certificates And Licenses

• Non-required.
• Certified auditor or other Quality Certification is a bonus

Supervisory Responsibilities

N/A

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. No hazardous or significantly unpleasant conditions. Standard office environment and/or remote work.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The above job description is not intended to be an all‑inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.

Pay & Benefits Summary

• BaseSalary: $85,000 - $95,000
• Medical, Vision, Dental Insurance Available
• 401K-discretionary2.5%employermatch
• Basic/Voluntary Term Life Insurance
• LongTermDisability
• HSAAccounts
• PTOYears 1and2,15days,Year3onwards20days
• 12paidpublicholidays
• Remoteworkenvironment(Eastcoasthoursrequiredinitially)
• Reimbursementfortravel(sales)

Legal Disclaimer(s)

Non Exempt: As a non‑exempt employee, your position is classified as eligible for overtime pay under the Fair Labor Standards Act (FLSA) and applicable state laws. You will be paid on an hourly basis (or salary basis, if applicable), and you will receive overtime compensation for all hours worked in excess of 40 hours in a workweek (or as otherwise required by state law). All overtime must be approved in advance by your supervisor.

BioWave is committed to the principles of equal employment opportunity and providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or accommodations to complete the application process or to perform the essential functions of this position, please contact [e-mail].