Quality Systems Associate

Quality Systems Associate

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.

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.

To perform this 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.

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.

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

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

• 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)

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 View email address on click.appcast.io.

This job description is intended to describe the general nature and level of work being performed. It is not intended to be an exhaustive list of all responsibilities, duties, or skills required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.