Associate Manager, Quality Engineer at Stryker

Arroyo, Puerto Rico, Puerto Rico

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Regulated ManufacturingIndustries

Requirements

B.S. in engineering, engineering management, or related discipline
Advanced English skills
Minimum of 3 years in Quality Assurance or related functional area
Minimum of 2 years as a supervisor of QA/RA function or equivalent experience
Minimum of 1 year of experience as people manager
Previous experience in the regulated manufacturing sector
Desired: ISO Lead Auditor training; Certified Quality Engineer (ASQ)
Desired: Previous experience in the Medical Devices sector

Responsibilities

Ensure full compliance with FDA, ISO13485, and other applicable regulatory and quality standards across operations and suppliers
Define, approve, and implement inspection, testing, and evaluation procedures to maintain product accuracy, precision, and reliability
Lead and participate in internal and external audits, including preparing documentation, managing corrective actions, and communicating results
Oversee complaint management, failure analysis, and nonconformance investigations, ensuring proper documentation and corrective actions
Supervise, coach, and develop a team of Quality Engineers, Technicians, Supervisors, and Coordinators, setting departmental goals and monitoring performance
Provide training on Quality Assurance and Regulatory Affairs topics to ensure organizational knowledge and compliance
Maintain and review product controls, acceptance activities, and environmental health and safety management practices to drive continuous improvement
Generate, review, and communicate detailed proposals, guidelines, and procedures to support decision-making across departments

Skills

ISO 13485

FDA Compliance

Quality Assurance

Internal Audits

External Audits

Corrective Actions

Failure Analysis

Nonconformance Investigations

Complaint Management

People Management

Regulatory Affairs

Supplier Management

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