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Danaher Corporation Senior Quality Engineer - Design Assurance in Shanghai, China

The Senior Quality Engineer applies biomedical engineering principles to execute the Quality Engineering function for medical devices. Ensure product compliance to 21 CFR Part 820, ISO 13485:2016, ISO 14971:2007/2019, China NMPA / CFDA requirements. Collaborate with cross-functional teams including Design Engineering, Systems Engineering, Regulatory, Program Management, Marketing and CMO to maintain adherence to Mammotome’s Quality Management System during planning, execution and implementation activities for New Product Development and Sustaining/VAVE Engineering initiatives. Lead the development and enforcement of Mammotome’s risk management activities to ensure patient and user safety through identification of risk-driven product requirements, and generation of risk management report/benefit analyses.

ESSENTIAL FUNCTIONS (ACCOUNTABILITIES/RESPONSIBILITIES)

RESPONSIBILITIES

  • Support New Product Development, Sustaining, and cost-saving projects by ensuring compliance of project activities and documentation to internal QMS requirements as well as external regulations and standards (CFDA, FDA, ISO, EN).

  • Provide assessments and review for planning, execution and implementation of design and manufacturing changes for commercialized products.

  • Drive design assurance into medical devices as the Quality Lead during all stages of design controls projects through support of user needs, product requirements, design specifications, design verification and validation strategies, usability studies, process qualifications, design reviews and transfer.

  • Responsible to generate and independently maintain project risk management file for NPD and sustaining projects. These include risk plans, hazard/failure mode effects analysis, risk mitigations and effectiveness checks, and risk management reports using principles from ISO 14971.

  • Assist supplier quality, CMO, manufacturing, marketing and other stakeholders to generate risk assessments using Design, Process, Software FMEAs, FTAs, etc. per requirements of ISO 14971.

  • Provide expertise in development and implementation of Confidence & Reliability strategy, statistical support, inspection, sampling plans, test methods during Design Verification and Validation using a risk-based approach.

  • Own applicable corporate quality policies and drive updates based on new standards or regulations for compliance, and/or process improvements for efficient use of QMS.

  • Assist in training company employees, other Design Assurance QEs on the principles of Quality and other QMS elements

  • Apply technical problem-solving methodologies to identify, adapt to shifting priorities, communicate, and resolve quality issues.

  • Assist with internal and external audits that include CFDA, FDA, ISO and MDSAP.

  • Own and execute applicable action plans to address relevant audit findings.

  • Provide assessment to resolve deviations and contribute to root cause investigations using various problem-solving techniques and tools for NCEs, CAPAs, Field Actions, Health Hazard Evaluations, and assesses effectiveness of corrective actions.

  • Other duties as assigned

CRITICAL SUCCESS FACTORS

  • Excellent communication skills, both written and verbal.

  • Solves complex problems; takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information ensuring compliance through the least burdensome approach.

  • Ability to gain followership and drive results.

  • Collaborate with the entire project team with a positive attitude to motivate change, continuous improvement, and engagement throughout the organization.

  • Able to work independently while maintaining strong collaborative working relationships.

  • Team player who can work well across a global organization.

  • The capacity to plan, organize, & complete projects on time. Excellent project management skills and ability to balance multiple responsibilities and deadlines.

REQUIRED SKILLS/EXPERIENCE

  • Equivalent of 4 – 5 years related work experience in a related Engineering field required.

  • Experience in the medical device industry (manufacturing, engineering, or technical capacity) required.

  • In-depth knowledge and experience of NMPA requirements, 21 CFR Part 820 and ISO 13485 Design Controls required.

  • Computer proficiency in Excel, Word, and PowerPoint required.

  • Fluent in English and Mandarin

DESIRED SKILLS/EXPERIENCE (Preferred Skills)

  • Experience and comprehensive understanding of Regulatory compliance in R&D.

  • NMPA, FDA, cGMP., cGDP and related audit readiness planning and implementation

  • FDA Class I and/or II medical device experience and EU Class III

  • Medical device software experience

  • Professional certifications (i.e., CQE, Six Sigma)

EDUCATION

  • Bachelor’s degree in a technical field (i.e., Biomedical Engineering, Bio Engineering, Mechanical Engineering, Material Science Engineering, Physical Sciences) required. Master’s degree preferred.

TRAVEL REQUIREMENTS

  • 10% including domestic and international locations.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

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