Quality Manager

Ingersoll Rand
Suzhou
Workplace: OnsiteFull timeFunction: Quality & Regulatory (Non-Software)Experience: 8+ yearsEducation: bachelorsSkills: ["Leadership","Communication","Stakeholder management","Proactive problem-solving","Change management"]

Lead the Suzhou quality department with a hands-on, strategic approach that connects quality performance to business outcomes. Ensure compliance with ISO 13485 and FDA QSR through QMS ownership, process validation, risk management (ISO 14971), and audit readiness. Drive CAPA, supplier quality, and data-driven improvements using SPC/MSA while partnering with key accounts to support market expansion across EU MDR and NMPA.

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FursaFursa
Ingersoll Rand
Ingersoll Rand
4 hours ago

Quality Manager

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Source: Company careers pageValidated by: Fursa AI
Last checked: 4 hours agoStatus: Live

Job Summary

Lead the Suzhou quality department with a hands-on, strategic approach that connects quality performance to business outcomes. Ensure compliance with ISO 13485 and FDA QSR through QMS ownership, process validation, risk management (ISO 14971), and audit readiness. Drive CAPA, supplier quality, and data-driven improvements using SPC/MSA while partnering with key accounts to support market expansion across EU MDR and NMPA.
Location: Suzhou
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Manager level

Key Responsibilities

  • •Lead, mentor, and develop the quality team (IQC, IPQC, QA, QC) and foster accountability and continuous improvement.
  • •Own and improve the QMS in strict compliance with ISO 13485 and FDA QSR (21 CFR Part 820).
  • •Oversee process validation (IQ/OQ/PQ) and lead quality requirement discussions with customers.
  • •Serve as primary liaison during external audits and ensure zero critical findings with timely closure of observations.
  • •Drive operational excellence through supplier quality, CAPA leadership, statistical methods (SPC/MSA), and continuous improvement initiatives.

Key Requirements

  • •Minimum bachelor’s degree in engineering, Chemistry, Polymer Science, or a related field.
  • •Minimum 8 years of quality experience in the medical device industry.
  • •Proven track record in a managerial role within a regulated manufacturing environment.
  • •Deep knowledge of ISO 13485, FDA regulations, GMP, and cleanroom standards (ISO Class 7).
  • •Strong leadership and communication skills in both English and Chinese; ability to influence stakeholders across all levels.
Experience:8+ yearsMedical device
Education:Bachelor's in engineering, Chemistry, Polymer Science, or related field
Skills:LeadershipCommunicationStakeholder managementProactive problem-solvingChange management
Languages:EnglishChinese
Tech Stack:ISO 13485FDA QSR (21 CFR Part 820)ISO 14971ISO Class 7QMSQSRIQ/OQ/PQCAPASPCMSAEU MDRNMPAAIDigitalization

Company Brief

Ingersoll Rand
Designs, manufactures, and services industrial equipment and technologies including air compressors, power tools, fluid management systems, and downstream industrial solutions for manufacturing, construction, and commercial customers worldwide.
Industry: Industrial Machinery
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Davidson, United States
Founded: 1871
WebsiteLinkedIn