Quality Engineer II

About the role

Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEM’s (original equipment manufacturers) to enhance the lives of patients worldwide and a provider of high-end niche batteries for specialized applications in the energy, military, and environmental markets.

The primary purpose of this position is to perform work which involves general engineering methods and tools, utilizing more advanced quality tools and concepts while developing your role as a quality engineering in the medical device industry.

Responsibilities

• Apply engineering concepts to resolve acute or chronic problems.
• Ensure Integer internal and external customer expectations are met or exceeded with the direction, instruction and guidance from more experienced engineers and managers in your organization.
• Adhere to Integer’s Values and all safety, environmental, security and quality requirements.
• 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.
• Review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
• Participate in continuous improvement projects.
• Assist with product transfers.
• Perform work on technical projects where you will 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.
• Interface with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies.
• Develop various inspection techniques and procedures to ensure product integrity to design specifications.
• Ensure that the disposition of non-conforming materials meet all necessary procedures and assure adequacy of corrective actions to prevent re-occurrence.
• Lead and manage complaint investigations.
• Participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
• Support internal quality audit activities, as applicable.
• Embed Quality– “I own Quality.”

Requirements

• Minimum Education: Bachelor’s degree in an engineering or related field and 3 years relevant experience.
• Candidates who do not meet the education requirement may be considered with 7+ years of relevant experience.
• 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.
• Solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual.
• Competencies in both written and oral communications.
• Maintain a calm demeanor that transcends the high energy, constantly changing production environment.
• Positive, can-do attitude with an underlying belief that failure is not an option.

Benefits

• Comprehensive benefits package with immediate eligibility including 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.
• 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

Pay

Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy.