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

Stryker Group; Skawina; Hybrid; PLN 50,000 - 70,000; Full time

Job summary

A global medical technology company is looking for a Product Transfer Quality Engineer to oversee quality during product transfers. Responsibilities include supporting global transfers, reviewing validation documentation, and ensuring compliance with quality standards. The ideal candidate will have expertise in quality activities and be able to identify risks during the transfer process. This role offers opportunities for continuous optimization and improvement in product transfer processes.

Responsibilities

• Support all product transfers globally.
• Interpret and guide on Regulations and Quality activities.
• Review and approve Validation/Qualification Documentation.
• Coordinate with Validation Consultants/Suppliers.
• Set and review supplier PPAP requirements.
• Point of contact for quality during product transfers.
• Identify and address product transfer quality risks.

Job description

Overview

Product Transfer Quality Engineering function that enables successful transfers by driving quality, cost transformation and service improvements for our customers whilst remaining compliant to both internal and external standards. Will also work in the New Product Introduction (NPI) framework to oversee quality related activities for a product relaunch.

Responsibilities

• Supporting all transfers globally, (Supplier to Supplier, Supplier to Stryker, Stryker to Supplier, Stryker to Stryker)
• Having 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.
• Reviewing and approving of Validation/Qualification Documentation and assume the Validation Representative role.
• Working with Validation Consultants/Contractors/Suppliers as required ensuring that Validations are completed as per corporate and divisional procedures.
• Set PPAP requirements with suppliers and review and approver supplier PPAP documentation.
• Point of contact for quality for product transfers at Scoping, Planning and Execution phases.
• Enable successful completion of product transfer to achieve its quality, cost and time requirements.
• Be able to identify PT quality risks/gaps and provide solutions to correct. Technical Quality Expert that sets quality strategy by utilizing a risk based approach around FAI’s, Inspection Certification, leveraging etc.
• Provide expertise for at least 2 quality speciality associated with product transfer
• Product Transfer Independent Reviewer as required
• Supports Product Transfer Process training where required
• Provides feedback to lessons learnt for each completed product transfer
• Drive continuous optimization of Product Transfer Process