Supplier Quality Engineer at Stryker

Cork, County Cork, Ireland

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Systems: OnePLM, Trackwise, SLMS, GIM
Process: PPAP, supplier readiness, NC/CAPA, barcode traceability, supplier audit response
Standards: EU MDR, ISO 13485, UDI supplier integration
Competencies: Self-directed, supplier-savvy, able to manage external/internal alignment, fast-paced readiness executor
Preferred Experience: MDR/UDI supplier implementation projects, Interaction with base business and divisional purchasing/QA, Barcode equipment readiness and supplier audits
Travel: 10%

Responsibilities

Lead supplier engagement related to barcode readiness, including kickoff meetings and implementation tracking
Review and approve supplier PPAPs, barcode validation evidence, and change notifications
Ensure supplier marking systems meet MDR durability and traceability criteria
Coordinate resolution of NCs, change control, and inventory disposition workflows
Collaborate closely with ME/QE teams to ensure supplier deliverables align with internal barcode standards and milestones
Maintain supplier audit trail and risk-based documentation for MDR compliance

Skills

Key technologies and capabilities for this role

PPAPTrackwiseOnePLMSLMSGIMEU MDRISO 13485UDINCCAPABarcode Traceability

Questions & Answers

Common questions about this position

What is the work arrangement for this Supplier Quality Engineer role?

The role offers a hybrid work flexibility.

What salary or compensation is offered for this position?

This information is not specified in the job description.

What are the required skills and tools for this role?

Required systems include OnePLM, Trackwise, SLMS, and GIM; processes cover PPAP, supplier readiness, NC/CAPA, barcode traceability, and supplier audit response; standards are EU MDR, ISO 13485, and UDI supplier integration. Key competencies are self-directed, supplier-savvy, able to manage external/internal alignment, and fast-paced readiness executor.

Who does the Supplier Quality Engineer collaborate with?

The role collaborates with Manufacturing Engineering (ME), Quality Engineering (QE), Regulatory Affairs, Supply Chain/Planning, Operations/Receiving Inspection, Project Management (PMO), IT/Supplier Portals, and Divisional SQ/Base Business Teams.

What experience makes a candidate stand out for this position?

Preferred experience includes MDR/UDI supplier implementation projects, interaction with base business and divisional purchasing/QA, and barcode equipment readiness and supplier audits.

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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