About the Role

The Quality Engineer is a systems-focused leader who drives cross-functional teams to continuously improve manufacturing process controls and elevate the quality and reliability of a growing organization, while maintaining compliance with regulations and customer requirements.

Essential Function/Duties*

Quality Systems and Processes - Continuous Improvement Support long-term effective working relationships with customers. Integrate effective CAPA and customer complaint processes that drive continuous improvement, utilizing problem-solving activities (A3, fishbone, 5 whys, cause & effect structure tree). Develop, improve, and optimize manufacturing, design control, and operational business processes. Apply Six Sigma methodologies to improve manufacturing processes and minimize variability. Manage change control based on product improvement, risk management, and design control processes. Engage in creation of manufacturing process controls (routers, BOMs, Inspection Plans, standard work, validation, etc.)

Quality Assurance Support the deployment of lean manufacturing practices. Assist with process validations and gauge repeatability studies. Author and maintain work instructions within the Quality Management System (QMS). Define inspection requirements and measurement methods for critical product features. Collaborate with customers to clarify inspection specifications and requirements. Participate in the development and maintenance of risk management documentation. Implement a risk-based approach to ensure product conformance with customer needs. Lead or support CAPA investigations, root cause analyses, and implementation of corrective actions. Manage nonconformances and liaison with external customers for complaint resolution. Monitor and ensure adherence to internal quality standards and external regulatory requirements. Represent the company during internal and external audits, addressing findings appropriately. Support Operations initiatives aligned with approved strategic goals. Coordinate and execute validation protocols for existing and new production processes.

Supplier Quality Evaluate and audit potential suppliers against defined criteria. Monitor supplier performance, identify opportunities to improve, and initiate action. Communicate supplier nonconformances and facilitate corrective action where appropriate. Collaborate with suppliers to strengthen performance and long-term relationships

Work Schedule / Supervision Position: Full-time: 40 hours/week, potential for more. Status: Exempt (Salary) position Recommended Education / Experience Education: BS in Engineering or Technology or equivalent experience Experience: 10+ years of manufacturing or process engineering experience with Medical Device Implants and Instruments (or equivalent) preferred. Proficiency with technical disciplines, such as root cause analysis, structured problem solving, corrective and preventive action, analytical methods, process validation, statistical techniques Proficiency with International Quality Systems and regulatory requirements, Preferred experience in a medical manufacturing environment (close tolerance machining, design control systems, and batch release management) Competency with office applications (e.g. Sharepoint, MS Word, Excel, Power Point); written and verbal presentation skills.

*See Job Description for more details*

Benefits Excellent benefits package including: health, dental, vision, life and disability insurance, parental leave, 401K, vacation, sick and holidays

About Able Medical Devices

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 & land management, mining & minerals, hardwood products, manufacturing, real estate, and medical device products. Please visit www.jmlongyear.com for more information.