Quality Engineer, Manufacturing Operations
As a Quality Engineer, Manufacturing Operations in Mahwah, NJ, you will support quality assurance, quality control, and continuous improvement activities across operations and other business functions. This role focuses on maintaining product and process quality, driving preventive quality initiatives, and supporting compliance with applicable regulations, standards, and internal quality requirements. You will work cross-functionally to promote quality throughout the product lifecycle and contribute to ongoing process improvements.
What You Will Do
Support quality assurance and quality control activities for products, processes, and manufacturing operations.
Lead and participate in quality improvement initiatives focused on reducing defects, improving compliance, and enhancing process performance.
Review, analyze, and investigate quality data to identify trends, risks, and opportunities for improvement.
Apply quality engineering principles, risk-based methodologies, and statistical techniques to support decision-making and process optimization.
Collaborate with cross-functional teams to address quality issues, implement corrective actions, and prevent recurrence.
Ensure compliance with applicable regulatory requirements, quality standards, and internal procedures.
Create, review, and maintain quality documentation, reports, and records in accordance with established requirements.
Represent the Quality function in cross-functional discussions, audits, projects, and operational activities.
What You Will Need
Required Qualifications
Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related engineering discipline.
Minimum 0 years’ of experience
Preferred Qualifications
Internship experience in quality, engineering, manufacturing, or related technical functions within regulated industries is strongly preferred.
Experience within the medical device industry.
Familiarity with ISO 13485, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP).
Knowledge of risk management methodologies and statistical analysis tools.
Experience supporting quality systems, manufacturing quality, or process improvement activities.
US20: $83,400 - $133,100 USD Annual
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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.