Location: Spencer, Indiana (US-IN), United States (US)
Hiring Manager: Jorge Eduardo Vasquez cabezas
Recruiter: Spencer Gregory Hale
Senior Quality Engineer
About the role:
Provides Process Quality Engineering support to Spencer manufacturing lines in Needles & Stents area, ensuring delivery of the highest quality product to the customer while supporting continuous improvement and quality initiatives. Partners with production and manufacturing engineers for operations support. Serves as a lead Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.
Your responsibilities include:
• Develop and update risk management deliverables.
• Lead or participate in projects to identify root cause and implement corrective and preventive actions.
• Performs/Collaborates in process validation and verification activities and review relevant documentation.
• Responsible for understanding nonconformance scope, implementing product stops, and determining release criteria. Responsible for investigating nonconformances and writing required documentation.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Evaluates the adequacy and compliance of systems, operations, and practices against regulations and internal requirements.
• Support cross-functional teams to perform assessments and implementation of design changes to existing products.
• Support internal and external audits and audit responses to existing products.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Mentoring junior engineers and technicians by providing technical guidance in identifying and resolving quality issues using engineering essentials and other related problem-solving tools and techniques.
• Drives cost of quality programs and initiatives.
What we’re looking for in you:
• BS in Engineering or related field, with 5+ years of relevant experience.
• Strong communication (oral and written) and presentation skills.
• Must be able to work in a team as well as independently under limited supervision.
• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO13485 Quality Standards.
• Self-starter with the ability to identify improvement opportunities.
• Demonstrated problem solving and statistical analysis capabilities.
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, Outlook. And familiar with Statistical Analysis software Minitab.
• Experience in medical device field in a manufacturing support role is a plus.
• Experience leading cross-functional teams and driving projects to completion.
• Prior interactions with the following disciplines: manufacturing engineering, CAPA, risk management, process validation, test method validation, supplier quality.
Requisition ID: 499801