{"id":2542854,"url":"https://alion.io/job/rhythm-link-quality-compliance-engineer","title":"Quality Compliance Engineer","company":{"id":3865759,"name":"Rhythm Link","domain":"rhythmlink.com","url":"https://alion.io/company/rhythmlink","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":null},"role":"Legal","role_family":"Legal","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Columbia, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":85000,"max":100000,"currency":"USD","period":"year","gross":null,"usd_annual":100000},"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-14T15:46:00Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-15T00:40:20Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"General Summary of the Position\nThe Quality Compliance Engineer is responsible for maintaining and improving the effectiveness of the Quality Management System (QMS) while ensuring compliance with applicable regulatory requirements, quality standards, and internal procedures. This position owns the Supplier Management program and works cross-functionally with Operations, Engineering, Regulatory Affairs, Manufacturing, and Supply Chain to ensure suppliers, products, and processes consistently meet established quality and regulatory requirements. The role also supports internal, external, and supplier audits; corrective and preventive action; post-market surveillance; recalls and market withdrawals; clinical evaluation reports; risk management; quality metrics; and continuous improvement activities.\nEssential Functions\n(Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills, and other characteristics. This list of tasks is not a comprehensive listing of all functions and tasks performed by this position. It does not imply that this position performs all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)\nMust be able to use office equipment including, but not limited to, phone, copier, and computer.\nMay be required to lift items up to 15 pounds in weight.\nMust be able to sit for extended periods of time at a desk.\nMay be required to travel periodically for supplier audits and other business needs.\nKnowledge, Skills, and Abilities\nSupplier Management\nMaintain Supplier Management Program. Including supplier evaluation, qualification, approval, monitoring, re-evaluation, and record maintenance using a risk-based approach.\nOversee supplier audits including planning, execution, documentation, and CAPA lifecycle.\nMaintain supplier qualification records, quality agreements, certifications, etc.\nManage supplier change notifications and second source qualifications.\nMonitor supplier quality and performance, prepare supplier performance and re-evaluation summaries for the Supplier Qualification Team and Management Review, as applicable.\nAudits\nConduct internal, external and supplier audits, including preparation, reporting, and closure.\nMaintain auditor qualifications and audit documentation.\nCorrective and Preventive Action (CAPA)\nLead or support investigations involving CAPAs, audit findings, supplier issues, complaints, and other quality events.\nFacilitate cross functional root cause analysis and risk-based CAPA actions using quality tools.\nDrive organizational CAPA accountability through timely completion and VOE.\nComplaint Management, Post Market and Performance Surveillance\nLead complaint intake, assessment, cross functional investigations, documentation, and closure.\nAnalyze complaints, clinical, regulatory, and product performance data for recurring issues, emerging risks, trends, regulatory, escalations, and corrective action triggers.\nCollaborate on Regulatory reporting and regulatory responses where applicable.\nMaintain post-market surveillance plans and reports, including Post Market Surveillance Reports, Periodic Safety Update Reports, and Summary Reports, as applicable.\nEnsure post-market information is incorporated into risk management, CAPA, and Management Review activities when required.\nMaintain clinical evaluation plans and reports. \nRecalls and Market Withdrawals\nContribute to the assessment, execution, documentation, and regulatory follow-up of recalls and market withdrawals, performing assigned tasks where applicable.\nQMS Support, Maintenance and Improvement Functions\nMaintain and improve assigned QMS processes, procedures, and records.\nSupport document and record control, training, change control, gap assessments, risk management, and electronic quality system validation, as assigned.\nDevelop, analyze, and report quality metrics, objectives, and key performance indicators.\nProvide quality and compliance guidance for supplier, product, process, and system changes.\nUse quality data and risk-based methods to identify risks and improvement opportunities.\nCollaborate with Operations, Engineering, Manufacturing, Supply Chain, Regulatory Affairs, and CMs to improve compliance, efficiency, supplier performance, and product quality.\nSupport compliance with ISO 13485, applicable FDA quality system requirements, and other applicable regulations and standards.\nCore Competencies\nStrong knowledge of QMS and regulated-industry compliance requirements.\nWorking knowledge of supplier qualification, supplier monitoring, supplier auditing, supplier corrective action, and quality agreements.\nAbility to apply risk-based thinking, root cause analysis, and quality engineering principles.\nAbility to analyze data, identify trends, and communicate conclusions clearly.\nStrong written communication, technical writing, organization, project management, and follow-up skills.\nAbility to manage multiple priorities and work independently while maintaining attention to detail.\nAbility to collaborate effectively with Operations, Engineering, Manufacturing, Supply Chain, Regulatory Affairs, and other functions.\nAbility to travel periodically for supplier audits or other business needs.\n\nEducation, Training, and Experience\nRequired\nDegree, in technical/scientific sciences and 2 years' experience in regulated industry\nOr 5 years' experience in medical device manufacturing environment, minimum of 3 years' experience in Quality role\nOr 8 years in a regulated industry environment. minimum of 4 years in a Quality role.\nPreferred\nExperience conducting internal or supplier audits.\nExperience applying ISO 13485, QMSR, EU MDR and/or MDSAP\nExperience with CAPA, change control, complaint handling, supplier management, or risk management.\nProfessional quality or auditing certification, such as ISO 13485 Lead Auditor, ASQ CQE, CQA, or equivalent, Lean Six Sigma.","description_format":"text","description_chars":5945,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Health & Medical Electronics"],"lifecycle":[{"event":"open","at":"2026-10-14T16:03:45Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":19,"reasons":["conf:2","win:early"],"computed_at":"2026-10-15T03:00:14Z"},"pay":{"stated_usd_annual":100000,"is_top_pay":false},"html_url":"https://alion.io/job/rhythm-link-quality-compliance-engineer","json_url":"https://alion.io/job/rhythm-link-quality-compliance-engineer.json","meta":{"generated_at":"2026-10-15T03:00:14Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per 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