Location: Spencer, Indiana (US-IN), United States (US)
Hiring Manager: Michael James Mulvaney
Recruiter: Spencer Gregory Hale
Senior Quality Engineer
About this role:
Responsible for providing support to a Production Area as a member of a Core that directly support production operations. You will be identifying, coordinating, and executing project priorities based on business and department objectives. You will also be required to have a sound understanding of the Quality Management System to ensure compliance and assist in troubleshooting quality issues as they arise. In addition, you will be expected to partner with other leaders within the organization to develop business strategy and implement quality and continuous improvement across the business
Your responsibilities will include:
- Providing team leadership to champion departmental or cross-functional initiatives. This includes providing direction, coaching, and mentoring to technical team personnel as well as providing guidance on daily work priorities.
- Overseeing effective execution of non-conformance management, CAPA’s, in-process monitoring and batch acceptance activities , testing, complaint management, and other ongoing manufacturing related activities.
- Providing technical guidance in identifying and resolving quality issues using engineering essentials and other related problem-solving tools and techniques.
- Partnering with cross-functional teams to ensure the development and execution of streamlined, robust solutions to quality and production processes are effectively implemented while still meeting organizational and regulatory requirements.
- Promoting programs and initiatives that implement best-in-class quality practices across the production processes.
- Focusing on continuous improvement by championing and fostering the execution of projects within the manufacturing area and across the site.
- Fostering a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
What we’re looking for in you:
- Bachelor’s degree with an Engineering or Science background, or equivalent demonstrated experience working and excelling in a technical environment.
- 5+ years of experience in quality/operations or equivalent
- Demonstrated effective change leadership and results-oriented
- Demonstrated problem-solving capabilities
- Strong business acumen and communication skills, with the ability to quickly establish impact and consequences
- Proficiency and the ability to teach, coach and mentor team on the use of SAP, Windchill and MES business objects for both problem solving and process improvement.
- Ability to coach, train, and mentor technicians and engineers in audit facing responsibilities for notified body interaction both in person and systematically.
- Ability to collaborate and influence across multiple, cross-functional teams
- Understanding and working knowledge of Medical Device Quality Systems and Regulatory Requirements
- Experience in Medical Device industry
Requisition ID: 501842