Quality Systems Associate

Job Description

Job Description

Quality Systems Associate

Quality Department

Reports to Sr. Manager Quality Systems

19 Newtown Turnpike, Westport, CT 06880

Full-time on-site position

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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.

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.

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

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 

• Working to intermediate knowledge of Microsoft Office applications (e.g., Word, Excel, PowerPoint, Outlook)
• Exposure to electronic Quality Management Systems is preferred

Certificates and Licenses:

• None 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.