Job Description
Job Description
The Quality Engineer is responsible for overseeing and manage the 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 Centersand Suppliers to develop and implement Quality improvement.
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.
Your Competencies:
- Communicate effectively with both internal and external customers
- Competent in documentation on product qualification, engineering changes, and Supplier Corrective Action Reports
- Capable of working with an international team and translate communication effectively to cross-functioning teams
- Ability to manage time to efficiently complete projects and tasks
- Translate and/or implement Standard Operating Procedures
- Ability to perform risk analysis such as DFMEA and FMEA
- Fundamental understanding or ability to comprehend test procedures, technical documents, and/or established industry standards such as ISO and ASTM.
- Read and translate test reports to effectively communicate results with cross functioning teams
- Write reports in various levels and in cogent way
- Understanding of technical drawings/specifications
- Technical writing skills
- Ability or knowledge to use basic measurement equipment such as calipers, pressure gauge, durometer, and multimeter
- Experience with working and communicating with 3rd party labs
- Verification and Validation including the ability to understand product function(s) and develop test programs to validate functions
- Microsoft Office including Outlook, Word, Excel (pivot table), Visio, SharePoint, and Power Point
- Understanding of GMP, ISO 13485, and ISO 90001 is a plus
Your Education and Experience:
- Bachelor’s Degree in engineering field (mechanical, electrical, quality); or 2-4 years related experience and / or training / or equivalent combination of education and experience. Experience in a manufacturing environment preferred.
- Solid work experience on mechanical design / quality / engineering discipline
- Interfacing and collaborating with suppliers and customers
- Proven track record of quality improvements on products and processes
Why Apply to Drive DeVilbiss…
Competitive Benefits, Paid Time Off, 401(k) Savings Plan
Pursuant to New York law, Drive DeVilbiss Healthcare provides a salary range in job advertisements. The salary for this role is $89,184.00 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 DeVilbiss is an Equal Opportunity Employer and provides equal employment opportunities to all employees and applicants for employment. Drive DeVilbiss 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 DeVilbiss complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.