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Stryker

Stryker

via Built In

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Senior Quality Engineer, New Product Introduction

Anywhere
full-time
Posted 8/1/2025
Verified Source
Key Skills:
Quality Engineering
FMEA
CAPA
PPAP
ISO 13485
Validations
Process Flow Mapping
Supplier Quality

Compensation

Salary Range

$70K - 90K a year

Responsibilities

Support design, testing, validations, and quality assurance activities for new products in regulated manufacturing environments.

Requirements

University degree in engineering, 2+ years in regulated industries like medical devices, knowledge of quality tools and standards such as ISO 13485, and strong communication skills.

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 8/3/2025

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