Quality Engineer II

Role Overview

• Perform work which involves general engineering methods and tools
• Utilize more advanced quality tools and concepts while developing your role as a quality engineer in the medical device industry
• Apply engineering concepts to resolve acute or chronic problems
• Ensure Integer internal and external customer expectations are met or exceeded with direction, instruction and guidance from more experienced engineers and managers
• Adhere to Integer’s Values and all safety, environmental, security and quality requirements including Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures
• Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality
• Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained
• Participate in continuous improvement projects.
• Assist with product transfers.
• Follow Integer’s standard quality management and production system methodologies to investigate opportunities for product and process improvements.
• Lead the generation and completion of protocols and reports for test method validations.
• Ensure that the disposition of non-conforming materials meet all necessary procedures and assure adequacy of corrective actions to prevent re-occurrence
• Support internal quality audit activities, as applicable.

Requirements

• At a minimum you have earned a bachelor’s degree in an engineering or related field
• 3 years relevant experience
• Candidates who do not meet the education requirement may be considered with 7+ years of relevant experience.
• Specialized Knowledge: awareness of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)
• Good knowledge in Microsoft Office
• Demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams.

Benefits

• medical, dental, vision, disability, life insurance, and adoption benefits
• Parental leave is available after one year.
• Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance.
• Employees are immediately eligible to participate in the 401(k) plan with company matching contributions.
• We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.