Senior Quality Systems Specialist

Senior Quality Systems Specialist

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 escalate 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).

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 listening 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

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:$75,000 - $80,000
• Medical, Vision, Dental Insurance Available
• 401K-discretionary2.5%employermatch
• Basic/Voluntary Term Life Insurance
• LongTermDisability
• HSAAccounts
• PTOYears 1and2,15days,Year3onwards20days
• 12paidpublicholidays
• 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 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.