Senior Quality Engineer at Stryker

Cary, Illinois, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s degree in science or engineering discipline
2+ years of experience in engineering, quality, manufacturing, or operations within a regulated industry
Preferred Requirements
Experience in validation activities
Experience with nonconformance (NC) and corrective and preventive actions (CAPA)
ASQ Certified Quality Engineer or equivalent certification
Understanding of pharmaceutical and/or medical device manufacturing processes
Knowledge of applicable regulations and standards, including FDA CFR Parts 210, 211, and 820; ISO 13485; ICH Q7/Q10
Training in Lean Six Sigma and CAPA/investigation methodologies

Responsibilities

Maintain KPIs to monitor process and product quality; perform analysis and interpret trends
Participate in and occasionally lead process improvement initiatives
Partner with Operations and Business functions to ensure product and process quality performance
Collaborate with Divisional QA, cross-functional teams, shared services, and suppliers to address key quality issues
Apply risk management principles to manufacturing operations
Support internal and external audits (regulatory agencies, notified bodies, competent authorities)
Lead medium-scope quality system projects
Participate in the development and review of process/equipment validations, qualifications, and measurement system analyses (MSAs)
Execute internal quality deliverables related to engineering changes, manufacturing transfers, and supplier-initiated changes
Initiate, contain, communicate, and support Commercial Holds for potential product escapes
Independently create and approve technical documentation
Lead basic root cause investigations, including CAPAs within area of responsibility

Skills

Process Validation

Equipment Qualification

MSA

CAPA

Root Cause Analysis

Risk Management

KPIs

Internal Audits

Supplier Quality

Manufacturing Transfer

Quality Assurance

Technical Documentation

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