Senior Staff Engineer, Product Transfer / NPI Quality Engineering (2 years contract) at Stryker

Skawina, Lesser Poland Voivodeship, Poland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Knowledge of and ability to provide interpretation and guidance on Regulations, Corporate and Site Local procedures as they relate to quality activities such as FMEA, MSA’s, Validations and Qualifications
Expertise for at least 2 quality specialties associated with product transfer
Technical Quality Expert that sets quality strategy by utilizing a risk-based approach around FAI’s, Inspection Certification, leveraging etc
Willingness to travel 10%

Responsibilities

Supporting all transfers globally (Supplier to Supplier, Supplier to Stryker, Stryker to Supplier, Stryker to Stryker)
Reviewing and approving Validation/Qualification Documentation and assuming the Validation Representative role
Working with Validation Consultants/Contractors/Suppliers as required, ensuring that Validations are completed as per corporate and divisional procedures
Setting PPAP requirements with suppliers and reviewing/approving supplier PPAP documentation
Serving as point of contact for quality for product transfers at Scoping, Planning and Execution phases
Enabling successful completion of product transfer to achieve its quality, cost and time requirements
Identifying PT quality risks/gaps and providing solutions to correct them
Acting as Product Transfer Independent Reviewer as required
Supporting Product Transfer Process training where required
Providing feedback to lessons learnt for each completed product transfer
Driving continuous optimization of Product Transfer Process

Skills

Key technologies and capabilities for this role

FMEAMSAValidationQualificationPPAPFAIInspection CertificationRisk ManagementQuality EngineeringNPIProduct Transfer

Questions & Answers

Common questions about this position

Is this a remote or hybrid role?

This is a hybrid role within the Product Transfer Quality Engineering function.

What is the salary or compensation for this position?

This information is not specified in the job description.

What key skills and expertise are required for this role?

The role requires knowledge of regulations and procedures for quality activities like FMEA, MSA’s, Validations and Qualifications, expertise in at least 2 quality specialties associated with product transfer, and experience reviewing validation documentation, PPAP, and risk-based approaches.

What does the team structure look like?

The role is within the QA Shared Services Product Transfer Team, responsible for quality related activities in product transfers globally.

How much travel is required for this position?

The role requires up to 10% travel.

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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