**This is an on-site position in Avondale, PA**

Medical, Dental, and Vision coverage starts on Day One!

Free life insurance, short and long-term disability insurance, Telehealth Appointments, and Employee Assistance Program.

Immediate vesting of 401(k) matching. Generous PTO and 11 Paid Holidays per year. And, most importantly...truly meaningful work!

Essential Duties, Responsibilities and Qualifications may include the following: (Other duties may be assigned.)

New Product Development:

• Coordinate resources to develop, document, and execute new product verification testing for products within and outside of existing product lines.
• Review and audits new product development activities and documentation to meet quality system requirements.
• Support investigation and analysis of quality resources needed for proposed projects in the product development process.
• Able to make decisions on complex technical matters related to areas such as processes, inspection and testing.

Process Improvement and Manufacturing Support:

• Identify, coordinate, and execute manufacturing and departmental process improvement projects.
• Review new technology equipment and process qualifications including IQ/OQ/PQ.

Quality Assurance:

• Lead resources to investigate, determine, and document root cause and corrective action for quality related issues such as corrective actions and non-conforming product.
• Review and audit product structures, drawings, specifications and procedures for completeness and application to ISO 13485 quality system.
• Investigate, determine, and respond to customer complaints including OEM complaints.
• Execute internal audits of quality system.
• Plan, execute and report on Quality Management System Metrics.

Leadership:

• Mentor interns, quality technicians and quality control inspectors.
• Lead discussions, projects driving continuous improvement of processes.

Personal Development:

• Attend all relevant training and actively pursues further training/education.
• Keep abreast of relevant developments in technology.
• Utilize statistical techniques and programs to make quality decisions.

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required Education and/or Experience

Minimum of a bachelor's degree (BS) in engineering, manufacturing design, or other related field from a four-year college or university; and at least 3 years related quality engineering experience in medical devices. Minimum of 2 years' experience in a regulated environment such as ISO 13485.

Other Useful Skills and Abilities:

• Documentation, process management, root cause investigation, quality analysis tool, and troubleshooting/problem solving experience or skills.
• Displays interpersonal and self-management skills.
• Experience with Microsoft Excel for data analysis, Microsoft Word for word processing, Microsoft office for email and calendar activities, and statistical analysis programs such as Minitab.
• Knowledge of manufacturing processes such as heat sealing, injection molding, machining and assembly.
• Prefer internal auditor certification in a regulated environment.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.