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Stryker

Stryker

via Indeed

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Senior Quality Engineer, New Product Introduction

Anywhere
Full-time
Posted 11/28/2025
Verified Source
Key Skills:
FMEA
CAPA
PPAP
Validations
ISO 13485
Quality Assurance
Manufacturing Processes

Compensation

Salary Range

$60K - 80K a year

Responsibilities

Support product design and testing, ensure quality standards, manage risks and validations, and collaborate with engineering and manufacturing teams.

Requirements

Requires engineering degree, 2+ years in regulated industries, knowledge of quality tools and ISO 13485, and strong English communication.

Full Description

What you will do: • Support the design and testing of new products. • Ensure that everything functions well and meets quality standards. • Identify and prevent potential problems (especially risks, defects, and inspection issues). • Ensure the product can be manufactured efficiently and safely. • Support validations (process, tool, and equipment testing). • Assist in the selection and approval of suppliers for new components or processes. • Lead quality activities during design transfer (when the product moves from design to production). • Work closely with engineering and manufacturing teams to ensure product quality and manufacturability. What you will need: Required: • University degree in engineering (or similar). • At least 2 years of experience in regulated industries, such as medical devices or pharmaceuticals. • Understanding of manufacturing processes and quality tools such as FMEA (Failure Mode and Effects Analysis), CAPA (Corrective and Preventive Actions), PPAP (Production Part Approval Process), validations, and inspections. • Knowledge of standards such as ISO 13485 (quality standard for medical devices). • Advanced English communication skills (oral and written). Desirable: • Experience with Process Flow Mapping (PFM) or process risk assessment. • Experience with non-conformity management. • Experience with supplier quality initiatives.

This job posting was last updated on 12/4/2025

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