Quality Assurance Manager at Stryker

Cary, Illinois, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s degree required; strongly preferred in Engineering, Science, or a related field
8+ years of experience working in a highly regulated environment, specifically in Quality, Manufacturing, or Engineering
Experience in the Medical Device or Pharmaceutical industry
3+ years of management experience
Maintaining current knowledge of applicable domestic and international regulations

Responsibilities

Oversee daily operations and projects within Quality Engineering and Calibration, including setting clear objectives, planning, data analysis, cost evaluation, training, and reporting
Ensure the Quality Engineering and Calibration team meets business needs through timely closure of quality investigations (NCs, CAPAs), change control approvals, process ownership, validation support, and active stakeholder collaboration
Set strategic direction for the quality engineering team to ensure attainment of site and network goals
Monitor KPIs and process measures for the assigned area of management
Manage quality metrics, provide updates, and drive improvements to ensure the team meets or exceeds performance targets
Identify and communicate to quality leadership issues that impact product purity, quality, safety or efficacy, regulatory compliance or business continuity
Identify and continually improve process effectiveness within the Cary site
Ensure key site representation at external regulatory body audits
Provide SME input into quality planning process and assessment of risk
Develop resource planning estimates to manage project workload and productivity
Lead cross-functional project team(s) through variety of project types including meetings for resolution of quality issues
Maintain strong relationships and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, and Marketing departments to ensure corporate goals and strategies are met
Attract, develop, and retain top talent and foster professional growth
Lead the Quality Engineering team, including calibration oversight for the facility
Ensure alignment with site and organizational goals, provide daily support to plant operations, and collaborate cross-functionally with Operations, Planning, Sourcing, HR, QC/QA, and Commercial Quality
Drive departmental objectives, champion site and network initiatives, and lead continuous improvement efforts
Empower a high-performing team by thoughtfully delegating responsibilities, ensuring robust training, and fostering a culture of accountability and growth through ongoing performance coaching and support

Skills

Quality Engineering

Calibration

CAPA

NC Investigations

Change Control

Process Validation

KPI Monitoring

Quality Metrics

Continuous Improvement

Regulatory Compliance

Audits

Data Analysis

Resource Planning

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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