NV_Quality Assurance Manager_Beijing at Stryker

Beijing, Beijing, China

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s degree or above in Biomedical Engineering, Pharmacy, Mechanical Engineering or related field
8+ years of progressive QA experience in interventional/implantable medical devices, including 3+ years leading teams
In-depth knowledge of NMPA regulation, such as ISO 13485, GMP
Proven track record of successfully hosting NMPA targeted or unannounced inspections
Fluent English (written & spoken) for global collaboration
Well-organized and logical thinking
Good at strategy making
Detail oriented
Professional communication skills
Team player
Patience and a great sense of responsibility
Leadership skills (People Management requirement): Allocate workload, set objectives, coach and develop QA team, identify training needs and succession plans aligned with Performance Management, manage cross-functional projects

Responsibilities

Develop annual QA strategy, budget and resource plan aligned with business needs and NMPA focus areas
Build, defend and continuously improve a best-in-class Quality Management System covering the full product life-cycle
Build and mentor a high-performing team capable of hosting unannounced NMPA inspections at both local and overseas sites
Lead the NV team to pass both domestic and overseas NMPA inspections with minimal business disruption
Establish proactive post-market surveillance programs for NV products, especially for VBP products; drive trending and risk-benefit reassessments
Review, analyze and report quality discrepancies; author dispositions and corrective actions for recurring issues
Support Operations and third-party warehouse management to ensure compliant product distribution and sales
Serve as primary interface with NMPA, provincial bureaus, and global QA/RA functions; maintain credibility and rapid escalation paths
Anticipate regulatory changes (e.g. random inspection for VBP products, overseas facility audits) and implement preventive actions before mandates take effect
Plan, execute and monitor the QA team objectives; track KPI closure rates
Own the local QA budget
Complete other assignments as directed by senior management

Skills

NMPA regulations

ISO 13485

GMP

Quality Management System

Post-Market Surveillance

Team Leadership

NMPA Inspections

Regulatory Compliance

Medical Devices QA

Risk Assessment

Audits

Biomedical Engineering

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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