quality-manager-qmr
From the author
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2. Use when leading management reviews, setting quality policy and objectives, monitoring quality KPIs and cost of quality, or exercising QMR governance and regulatory oversight responsibilities.
Install
npx skills add alirezarezvani/claude-skills --skill quality-manager-qmr -a claude-code
Installs to .claude/skills/quality-manager-qmr/ · Each command fetches the skill straight from GitHub with the open skills CLI.
Byte-identical to the scanned commit, with the repository’s licence and a SOURCE.txt.
Want your agent to suggest skills while you type? See how to use skills from your IDE.
Safety checks on SKILL.md
- Ships scripts we have not reviewedLow
Why 88
aiqbench computes the trust score from public signals. It is not a security audit, so read a skill before you install it.
Similar skills
Closest to this one by what they do and when they are used.
- qms-audit-expertalirezarezvani/claude-skillsISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use when planning internal audits, executing audits, classifying findings, preparing for external audits, or managing an audit program.Science★ 28.7K
- iso-13485-certificationforyourhealth111-pixel/Vibe-SkillsComprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.Science★ 3.8K
- quality-managementcbrock84/headcountBuilds quality into operations — defining standards, catching defects at the right point, root cause analysis, and continuous improvement. Use this to reduce a defect or error rate, design quality controls into a process, run a root cause analysis, respond to a customer quality complaint, or set up quality metrics that drive behavior.Design★ 2.1K
- alterlab-iso13485AlterLab-IEU/AlterLab-Academic-SkillsPrepares ISO 13485 certification documentation for medical device Quality Management Systems (QMS) — gap analysis of existing documentation, Quality Manuals, required procedures and work instructions, and Medical Device Files. Use for ISO 13485 QMS documentation, conducting a documentation gap analysis, drafting a Quality Manual or SOP/work instruction, assembling a Medical Device File, identifying missing documentation for medical device certification, or when medical device regulations, QMS certification, FDA QMSR, or EU MDR are mentioned. Part of the AlterLab Academic Skills suite.Science★ 78
- cm-product-managerkingxiaozhe/cm-workflow产品经理 Skill，负责需求分析、用户故事与验收标准编写、歧义清单生成、变更影响分析、业务验收走查；把关型角色，不做技术设计与技术测试Other★ 97
- quality-nonconformancemturac/everything-openai-codexCodified expertise for quality control, non-conformance investigation, root cause analysis, corrective action, and supplier quality management in regulated manufacturing. Informed by quality engineers with 15+ years experience across FDA, IATF 16949, and AS9100 environments. Includes NCR lifecycle management, CAPA systems, SPC interpretation, and audit methodology. Use when investigating non-conformances, performing root cause analysis, managing CAPAs, interpreting SPC data, or handling supplier quality issues.Finance★ 83
Ratings & reviews
—
no reviews
Tried this skill? Rate it to help others. Sign in
Discussion
Join the discussion. Sign in