Quality Systems Associate

About BioWave

BioWave 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, BioWave 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.

Job Description

Support the maintenance and day-to-day administration of BioWave's Quality System. This entry-level role assists with document control, training records, change management, nonconformances, CAPA, complaints, and risk management activities, while helping the organization maintain compliance and quality objectives for BioWave.

Responsibilities

• Assist with maintaining quality system records and reports, including CAPA, nonconformance, document control, training, and audit tracking logs.
• Support CAPA and nonconformance processes by following up on due dates, collecting documentation, and helping ensure records are complete and current.
• Assist with document control activities, including formatting, routing, issuance, revision updates, and archival of quality system documents.
• Help support internal and external audit readiness by organizing records, preparing documentation, and assisting with follow-up actions.
• Maintain training records and help ensure employees are assigned and complete required quality system training.
• Provide administrative and coordination support for quality system improvements and electronic QMS activities, as assigned.
• Additional responsibilities as required by management.

Required Experience & Skills

Competencies:

• Achievement focus – demonstrates persistence and overcomes obstacles. Measures self against 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. Selects and uses appropriate communication methods.
• Quality Management – Foster's quality focus in 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 success of team above own interests.

Qualifications

• Bachelor's degree from a four-year college or university, or equivalent combination of education and experience, with approximately two years of related quality systems, quality assurance, or regulated industry experience.
• Experience in a medical device company or other ISO 9001/13485-regulated environment is preferred.
• 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).
• 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.
• 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.
• Working to intermediate knowledge of Microsoft Office applications (e.g., Word, Excel, PowerPoint, Outlook)
• Exposure to electronic Quality Management Systems is preferred
• Certified auditor or other Quality Certification is a bonus

Pay & Benefits

• Base Salary: $50,000-$60,000
• Medical, Vision, Dental Insurance Available
• 401K- discretionary 2.5% employer match
• Basic/Voluntary Term Life Insurance
• Long Term Disability
• HSA Accounts
• PTO Years 1 and 2, 15 days, Year 3 onwards 20 days
• 12 paid public holidays
• Remote work environment (East coast hours required initially)
• Reimbursement for travel(sales)

Schedule

Full-time on-site position at 19 Newtown Turnpike, Westport, CT 06880. Reports to Sr. Manager Quality Systems.