Senior Quality Engineer, New Product Introduction at Stryker

Arroyo, Puerto Rico, Puerto Rico

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

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
Desirable: Experience with non-conformity management
Desirable: Experience with supplier quality initiatives
Willingness to travel 20%

Responsibilities

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

Skills

FMEA

CAPA

PPAP

ISO 13485

validations

inspections

Process Flow Mapping

PFM

non-conformity management

supplier quality

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