Quality Engineer

Who Is Drive Medical.. Drive Medical has become a leading manufacturer of medical products with a strong and consistent track record of growth achieved both organically and through acquisitions. We are proud of our high-quality, diverse product portfolio, channel footprint and global operating scale. Our products are sold into the homecare, long-term care, retail, and e-commerce channels in more than 100 countries around the world. Leading the World with Innovative Healthcare Solutions that

Enhance Lives Summary:

The Quality Engineer is responsible for overseeing and managing the total quality process (product development, supplier quality management, and post launch services support) and to ensure the quality of the product can satisfy specification, customer, and compliance requirement. This position requires collaboration with Product Management, Supply Chain, International Team, Post Market Surveillance, Distribution Center sand Suppliers to develop and implement Quality improvement. This role may require occasional travel. The Quality Engineer s day-to-day will involve collaborative execution of product reviews, development of testing protocols, evaluation and investigation of complaints, investigation of quality issues, product record development and implementation of the Engineering Changes Process. This is a hybrid role requiring up to two days on-site per week in Port Washington, NY, or Dayton, NJ, depending on the candidate s location. Major Responsibilities Support new product development by providing quality expertise including qualification requirements based on applicable standards and regulatory requirements, developing testing protocols, and leading the product qualification process. Manage the product qualification process, ensuring adherence to product specifications and regulatory requirements. Support the qualification of private-label and retail items. Develop testing protocols based on product intended use and applicable regulatory requirements. Provide Quality Engineering input for the development of labeling and packaging specifications Lead the risk assessment process, analyze complaint data and collaborate with the cross functional teams and suppliers in the investigation and mitigation of potential risks. Manage the supplier engineering change control process, collaborating with cross-functional teams to review and approve product changes, assess potential impacts, and ensure required documentation supports product safety and regulatory compliance. Assist cross-functional teams with product inquiries and external requests. Collaborate in the development of product records, providing input on product requirements, including testing protocols, labeling specifications, applicable standards, and regulatory requirements. Maintain key process indicators metrics, report findings to management, identify areas for improvement, and lead process enhancement initiatives. Investigate customer complaints, evaluate nonconforming products, and work with suppliers to determine root causes and implement corrective actions. Lead investigations of nonconforming materials, provide input on material disposition, and collaborate with suppliers to resolve quality issues. Participate in the CAPA process, evaluating internal process failures and implementing corrective actions. Provide weekly or regular updates on projects or outstanding issues to key stakeholders and provide clear action items and expectations. Develop and update work instructions, forms and procedures as needed for existing and new processes.

Competencies:

Communicate effectively with both internal and external customers. Ability to define problems, analyze data, establish facts, and draw conclusions. Experience using root cause analysis tools. Ability to read test reports and effectively communicate results with cross-functional teams. Experience using time management skills to prioritize tasks and meet multiple project deadlines. Develop strategies to address complex issues. Proficient in MS Office products (Word, Excel, PowerPoint, Outlook), with intermediate Excel skills (e.g., conditional formatting, pivot tables, formulas, Pareto charts, and diagrams). Interpret technical drawings, specifications, and test reports. Strong technical writing skills. Ability to use or knowledge of basic measurement equipment such as calipers, pressure gauges, durometers, and multimeters. Strong knowledge of industry standards, including 21 CFR 820, ISO 13485 and GMP (preferred). Excellent analytical, decision-making, and problem-solving skills. Ability to comprehend and apply test procedures, technical documents, and industry regulations. Reporting Relationships and Supervision This position reports to the Manager, Quality Engineering and does not have any direct reports.

Education:

Bachelor s degree in engineering Proven performance in the medical device industry and increasing responsibility within Quality roles. Minimum of 2+ years related experience Why Apply to Drive Medical Competitive Benefits, Paid Time Off, 401(k) Savings Plan Pursuant to New York law, Drive Medical provides a salary range in job advertisements. The salary range for this role is $89,000 to $100,000.00 per year. Actual salaries may vary depending on factors such as the applicant s experience, specialization, education, as well as the company s requirements. The provided salary range does not include bonuses, incentives, differential pay, or other forms of compensation or benefits which may be offered to the applicant, if eligible according to the company s policies. Drive Medical is an Equal Opportunity Employer and provides equal employment opportunities to all employees and applicants for employment. Drive Medical strictly prohibits and does not tolerate discrimination against employees, applicants, or any other covered person because of race, color, religion, gender, sexual orientation, gender identity, pregnancy and/or parental status, national origin, age, disability status, protected veteran status, genetic information (including family medical history), or any other characteristic protected by federal, state, or local law. Drive Medical complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.