Director, Quality Assurance at Stryker

Cork, County Cork, Ireland

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Medical Devices, ManufacturingIndustries

Requirements

Expertise in leading Quality Assurance teams for Medical Franchise manufacturing outside the US
Ability to deliver strategic, compliance, and business objectives
Skills in identifying opportunities for efficiencies, risk-based approaches, and competencies aligned with GQO and customer strategies
Strong collaboration skills with partner areas including Procurement, AO, Operations, and Quality Leadership
Leadership capacity within Manufacturing Quality Assurance structure
Technical and scientific expertise in site sterilization, microbiology execution, metrology, process development, and laboratory testing
Experience in deploying manufacturing & automation systems (e.g., MES, CMMS, SPC, ERP, PLM, PDM)
Expertise in establishing and maintaining compliance with global quality system requirements
Experience interfacing with regulatory agencies (e.g., FDA, notified bodies) for audits
Knowledge of quality control processes including acceptance activities, in-process controls, final inspection, product release, and environmental control
Ability to manage product/process deviations, corrective actions, and product/patient risk
Experience supporting product transfers
Skills in building and leading high-performing QA teams and shaping operating models
Leadership in promoting positive employee environment, open communication, engagement, development, trust, flexibility, teamwork, and inclusiveness
Expertise in leading organizational change and cultivating innovation for large-scale operational transformations in a global context
Ability to engage in plant network strategy evaluation and develop QA PT roadmaps aligned with GQO strategy

Responsibilities

Lead Quality Assurance teams for Medical Franchise manufacturing outside the US
Develop and lead quality within operations and other business functions
Ensure organization’s conformance to customer requirements and regulatory standards
Recognize and pursue opportunities for efficiencies through continuous improvement, manufacturing changes, lean activities, and leverage
Provide technical and scientific support in sterilization, microbiology, metrology, process development, and laboratory testing
Lead/partner in deployment of manufacturing & automation systems to optimize processes, validation, supply chain, and operations
Establish and maintain compliance with global quality system requirements
Ensure site(s) maintain certification to regulatory bodies and interface with agencies for audits
Oversee quality control processes including acceptance, in-process controls, final inspection, product release, and environmental control
Manage product/process deviations, implement corrective actions, and lead risk management
Support execution of product transfers
Build high-performing QA team and community, shape operating model, standardize processes
Champion positive employee environment and culture of trust, flexibility, teamwork, and inclusiveness
Demonstrate leadership in organizational change and innovation for global transformations
Engage in plant network strategy and develop QA PT roadmap for growth
Ensure adherence to Quality KPI performance indicators, address trends/deviations, and monitor global forums for improvements
Develop quality strategies with global alignment

Skills

Quality Assurance

Regulatory Compliance

Continuous Improvement

Lean Manufacturing

Sterilization

Microbiology

Metrology

Process Validation

MES

CMMS

SPC

ERP

PLM

PDM

Automation

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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