Senior Quality Systems Specialist

About the role

BioWave is a Medtech company redefining pain management through innovative, non-invasive technology. This position reports to the Sr. Manager Quality Systems and is based full-time on-site.

Responsibilities

• 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).
• 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.
• 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).

Qualifications

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

Competencies

• Achievement focus – demonstrates persistence and overcomes obstacles.
• 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 – fosters 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.

Pay & Benefits

• Base Salary: $75,000 - $80,000
• Medical, Vision, Dental Insurance Available
• 401K-discretionary 2.5% employer match
• Basic/Voluntary Term Life Insurance
• Long Term Disability
• HSAAccounts PTO
• 15 days (Years 1 and 2), 20 days (Years 3 onwards)
• 12 paid public holidays
• Remote work environment (East coast hours required initially)
• Reimbursement for travel (sales)