Ensure compliance with regulatory standards, conduct audits, implement inspection methods, investigate product failures, and support new product validation.
Work Flexibility: Onsite
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 contractor’s legal duty to furnish information.
What You Will Do
- Ensure continuous compliance with regulatory standards, including FDA and Good Manufacturing Practices, across manufacturing processes.
- Conduct internal and external audits; deliver training sessions on quality assurance procedures and regulatory requirements.
- Design and implement inspection and testing methods, including statistical process control, to maintain product precision and reliability.
- Stop production processes when non-conforming product conditions are identified and initiate containment actions.
- Develop and maintain documentation for inspection, testing, and validation activities, ensuring traceability and compliance.
- Investigate product and process failures using structured problem-solving methods (e.g., root cause analysis) and implement corrective actions.
- Collaborate with suppliers to resolve quality issues, standardize inspection methods, and support vendor audits and performance improvement.
- Support new product introduction and validation activities, including product, process, and packaging validation.
- Bachelor’s degree in Engineering or related discipline.
- Minimum 5 years of experience in Quality Engineering or a related field.
- Knowledge of inspection methods in electromechanical and/or mechanical manufacturing.
- Experience applying quality tools such as statistical process control and root cause analysis.
- Experience working in a regulated manufacturing environment.
- Intermediate level of English.
- Engineering license (EIT or PE).
- Formal training or certification in Quality Assurance methodologies.
United States of America Pay Ranges:
- Puerto Rico: $69,500 - $110,900 USD Annual
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 contractor’s legal duty to furnish information.
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