The Quality Engineer champions a systems-based approach to comply with regulations, continuously improve, and ensure customer requirements are met.
- Implement a risk-based approach to ensure product conformance with customer needs.
- Manage nonconformities and liaison with external customers for complaint resolution.
- Lead or support problem-solving activities within the CA/PA system.
- Monitor and ensure compliance to internal quality system and external industry regulations.
- Represent Able during internal and external audits, dispositioning feedback appropriately.
- Support approved Operations initiatives.
- Evaluate and audit potential suppliers against pre-established acceptance criteria.
- Monitor supplier performance, identify opportunities to improve and initiate action.
- Communicate supplier nonconformities and facilitate corrective action where appropriate.
- Develop and maintain inspection and quality control procedures.
- Define how features of products will be measured based on critical features.
- Support inspection method validation.
- Perform acceptance activities supporting multiple activities (e.g. receiving, in-process, final inspection, & documentation).
- Facilitate measurement equipment calibration and maintenance.
- BS in Quality, Engineering, Technology, or equivalent experience.
- Experience or demonstrated ability with technical disciplines such as structured problem solving, analytical methods, process & design validation, statistical techniques, metrology.
- Familiarity with International Quality Systems and regulatory requirements.
- Proficiency with lean tool techniques (e.g. standard work, 5S, Kanban, visual management).
- Preferred experience in a medical manufacturing environment (close tolerance machining, design control systems, and batch release management).
Excellent benefits package including: health, dental, vision, life and disability insurance, parental leave, 401K, vacation, sick and holidays.
Able Medical Devices is a leader in contract manufacturing and development. Able partners with companies seeking first class, outsourced services from design & development to comprehensive finished goods manufacturing. The company’s extensive expertise includes working with surgeons and OEM’s in spine, trauma and cardiothoracic markets. Able specializes in developing full surgical systems as well as custom instrumentation. Please visit our website www.ablemedicaldevices.com to learn more about the company.
Able Medical Devices is a portfolio organization of the J.M. Longyear family of companies. Headquartered in Marquette, Michigan, J.M. Longyear is a privately held asset-based manager with 150 years of experience growing long-term value. Longyear’s interests span a vast spectrum of markets that include forestry and land management, mining & metals, hardwood products, manufacturing, real estate, and medical device products.