Engineer, Quality Assurance

Lakeland, FL - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Onsite

Stryker is hiring anEngineerQuality AssuranceinLakeland FLto supportSustainability Solutions!In this full-time role youll provide quality engineering support across assurance control and preventive activitiesdriving continuous improvement in both products and processes.

You will play a key part in supporting the transfer of manufacturing operations from our Lakeland site which is expected to remain operational through the end of 2026. This is a great opportunity for someone early in their engineering career to gain hands-on experience in quality within a global medical technology leader. This role can also qualify for a retention bonus.

What You Will Do:

Investigate customer complaints in accordance with FDA and global regulatory requirements ensuring timely and compliant resolution.
Communicate with customers field service and sales teams to collect data necessary for complaint investigations.
Gather analyze and present Post Market trending data (e.g. service reports complaints MDR/MIR cost of poor quality) to identify opportunities for quality improvements.
Lead initiatives to improve Medical Division Quality metrics through data-driven actions and cross-functional collaboration.
Lead and/or support NC and CAPA process by working with multifunctional teams (Ex: R&D Operations Manufacturing Engineering Field Service and Sales) to drive root cause and resolution. Document accurate and thorough investigation results within the Complaint Handing System.
Support Engineering Change Orders (ECOs) and Process Change Orders (PCOs) including development of verification/validation rationale for post-market issues.
Maintain and update product risk management documentation throughout the product lifecycle including risk analyses and mitigation strategies.
Contribute to post-launch quality assurance by monitoring product performance and integrating voice-of-customer feedback into design and quality specifications.

Monitor compliance to Medical Quality Procedures FDA and other global health authority regulations.
Support field action-related activities i.e. investigations Health Hazard Evaluations (HHEs) and presentations.
Support internal and external audits (FDA ISO MDSAP etc.).

What You Need:

Required:

Bachelors degree in engineering science or related field.
0 years of experience.

Preferred:

Industry or regulation knowledge is a plus! (FDA QSR ISO 13485 etc.)
Internship or hands-on experience in engineering quality assurance or manufacturing within a regulated industry.

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information.

Work Flexibility: OnsiteStryker is hiring anEngineerQuality AssuranceinLakeland FLto supportSustainability Solutions!In this full-time role youll provide quality engineering support across assurance control and preventive activitiesdriving continuous improvement in both products and processes.You wi...

Work Flexibility: Onsite

What You Will Do:

Investigate customer complaints in accordance with FDA and global regulatory requirements ensuring timely and compliant resolution.
Communicate with customers field service and sales teams to collect data necessary for complaint investigations.
Gather analyze and present Post Market trending data (e.g. service reports complaints MDR/MIR cost of poor quality) to identify opportunities for quality improvements.
Lead initiatives to improve Medical Division Quality metrics through data-driven actions and cross-functional collaboration.
Lead and/or support NC and CAPA process by working with multifunctional teams (Ex: R&D Operations Manufacturing Engineering Field Service and Sales) to drive root cause and resolution. Document accurate and thorough investigation results within the Complaint Handing System.
Support Engineering Change Orders (ECOs) and Process Change Orders (PCOs) including development of verification/validation rationale for post-market issues.
Maintain and update product risk management documentation throughout the product lifecycle including risk analyses and mitigation strategies.
Contribute to post-launch quality assurance by monitoring product performance and integrating voice-of-customer feedback into design and quality specifications.

Monitor compliance to Medical Quality Procedures FDA and other global health authority regulations.
Support field action-related activities i.e. investigations Health Hazard Evaluations (HHEs) and presentations.
Support internal and external audits (FDA ISO MDSAP etc.).

What You Need:

Required:

Bachelors degree in engineering science or related field.
0 years of experience.

Preferred:

Industry or regulation knowledge is a plus! (FDA QSR ISO 13485 etc.)
Internship or hands-on experience in engineering quality assurance or manufacturing within a regulated industry.

Travel Percentage: 10%

Key Skills

Test Cases
Performance Testing
Quality Assurance
SOC
Agile
Debugging
Jira
Perl
Software Testing
Test Automation
Scripting
Selenium

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About Company

Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more

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