Senior Quality Systems Specialist

We need to output HTML fragment with sections: About the role? Actually the posting includes "About BioWave" and "Vision & Mission". The instructions: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We should only include sections when there is real specific content. We need to preserve all substantive info, remove boilerplate like legal disclaimer, EEO, application instructions, etc. Also remove duplicated lines. We need to decide sections: Possibly "About BioWave" could be considered "About the role"? But they said use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we should map content accordingly. We have: - About BioWave (company description) - Vision & Mission (maybe part of About the role? Could be separate but not in list. Might be considered part of About the role? The instruction says use those headings as examples, not exclusive? It says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should stick to those headings; we can include others only if they match? Probably we should only use those headings. So we need to map content to those categories. We have: - Responsibilities: Essential Duties and Responsibilities list. - Requirements: Qualifications section (Education/Experience, Language Ability, Mathematical Ability, Reasoning Ability, Computer Skills, Certificates And Licenses, Supervisory Responsibilities N/A maybe skip). - Skills: Competencies list. - Benefits: Pay & Benefits Summary includes salary range and benefits. - Pay: maybe separate but we can combine Pay & Benefits? The instruction says include a section ONLY when posting has real specific content. We have Pay & Benefits Summary with salary and benefits. Could split into Pay and Benefits sections, but we could also combine into Benefits? They said prefer a few substantive sections over many thin ones. So we could have a single "Benefits" section that includes both pay and benefits. But they gave separate headings for Pay and Benefits. Might be better to have Pay and Benefits separate if content exists. We have salary range and benefits details. So we can have Pay section with salary range, Benefits section with insurance, 401k, life, disability, HSA, PTO, holidays, remote work, travel reimbursement. - Schedule: Not explicitly given; we have Full-Time, On Site Position, and mention remote work environment (East coast hours required initially). Could infer schedule: Full-Time, On Site. But they said never create Schedule section unless posting actually states them. It does state Full-Time, On Site Position. That's schedule info. So we can include Schedule section with that. - About the role: Could include company description and vision/mission. That seems appropriate. Thus sections: About the role, Responsibilities, Requirements, Skills, Pay, Benefits, Schedule. We must not repeat job title as heading. No Job ID. We must remove boilerplate: Legal Disclaimer(s), EEO, etc. Also remove "Reasonable accommodations may be made..." repeated many times; we can keep once? Probably we should remove those lines as they are boilerplate. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we should remove all those "Reasonable accommodations may be made..." lines. Also remove "Non Exempt:" legal disclaimer, EEO statement, contact email, etc. We need to preserve substantive info: company description, vision/mission, job description summary, essential duties list, competencies list, qualifications details, pay & benefits summary. We need to format lists with

• . For prose use

  . We need to ensure we don't include filler like "N/A". Supervisory Responsibilities: N/A - we should drop that line. We need to ensure we don't include placeholder like "commensurate with experience" etc. Not present. Let's extract content. About BioWave paragraph: "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." We could combine into About the role section. Job Description summary: "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." That's prose. Essential Duties and Responsibilities list: each bullet starts with a verb. We'll list as

  • . Competencies list: bullet points. Qualifications: includes Education/Experience, Language Ability, Mathematical Ability, Reasoning Ability, Computer Skills, Certificates And Licenses. We'll format as
    • each. Pay: BaseSalary: $85,000 - $95,000. Benefits: list: Medical, Vision, Dental Insurance Available; 401K-discretionary 2.5% employer match; Basic/Voluntary Term Life Insurance; LongTerm 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. We should also maybe include location? The posting includes address: 19 Newtown Turnpike, Westport, CT 06880. That's location info. Could be part of About the role? Not specified heading. Could be included in About the role as prose. But we might add a separate section? Not in list. Probably include location in About the role paragraph. We must not include duplicated lines. Ensure we don't repeat "Reasonable accommodations may be made..." etc. Now produce HTML fragment. Structure:

      About the role

      ... company description, vision/mission, location, job description summary ...

      Responsibilities

      • ... each duty ...

      Requirements

      • ... each qualification bullet ...

      Skills

      • ... each competency ...

      Pay

      Base salary: $85,000 - $95,000.

      Benefits

      • ... each benefit ...

      Schedule

      Full-Time, On Site position.

      We need to ensure we don't include extra whitespace? It's fine. Now craft the content. About the role paragraph: combine company description, vision/mission, location, job description summary. Let's write: "BioWave is a Medtech company redefining pain management through innovative, non‑invasive technology that delivers powerful relief without drugs or surgery. The company offers a range of products tailored to different markets, providing effective, customized pain relief solutions where they’re needed most, backed by clinical evidence and real‑world results. Trusted by healthcare professionals, athletes, veterans, and individuals, BioWave targets pain at its source for long‑lasting results. Vision: 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. Mission: To help people win their battle with severe pain. Located at 19 Newtown Turnpike, Westport, CT 06880, this role ensures compliance through the development, implementation, and maintenance of the Business Unit’s Quality System, including electronic and paper‑based methods for document control, training, change management, nonconformances, CAPA, complaints, and risk management, while upholding BioWave’s Quality Objectives and KPIs." That seems good. Now Responsibilities list: extract each duty. List from posting: - 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). - Additional responsibilities as required by management. We'll include all except maybe the last "Additional responsibilities as required by management." It's generic but still substantive? It's a bit generic but still part of responsibilities. Could keep. Now Requirements list: extract each bullet. From Qualifications: - 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. - Supervisory Responsibilities: N/A (we will drop). We'll format each as
    • with the content. Now Skills list: Competencies bullet points. List: - 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