Quality Engineer II

About the Company

Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs (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. We are guided by six core Values: Customer focus, Innovation, Collaboration, Inclusion, Candor, and Integrity. Working at Integer means being part of a team passionately pursuing excellence in all that we do.

Responsibilities

• Apply engineering concepts to resolve acute or chronic problems, ensuring internal and external customer expectations are met or exceeded with guidance from experienced engineers and managers.
• Adhere to Integer’s Values and all safety, environmental, security, and quality requirements, including QMS, FDA regulations, and company policies.
• Manufacturing Support:
  • Support regulatory and agency inspections, audits, investigations, and inquiries regarding product design and manufacturing quality.
  • Monitor manufacturing of assigned products, ensuring compliance with DMR, providing deviation/waiver guidance, and maintaining complete and correct Device History Records.
  • Review changes to Bill of Materials (BOMs), Assembly Procedures, Drawings, Component Specifications, FMEAs, Control Plans, etc.
  • Participate in continuous improvement projects and assist with product transfers.
  • Collaborate with others to investigate opportunities for product and process improvements using Integer’s standard methodologies.
• Create Test Methods:
  • 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, coordinating process validations and capability studies.
  • Recommend process monitoring devices and develop inspection techniques and procedures to ensure product integrity.
  • Write, approve, and implement Incoming, In-Process, and Final Inspection procedures.
• Support Non-Conforming Material Process:
  • Ensure disposition of non-conforming materials meets all procedures and adequacy of corrective actions to prevent recurrence.
  • Lead and manage complaint investigations.
  • Participate in plant CAPA activities, including data and trend analysis for complaints, supplier quality, nonconforming material, training effectiveness, and root cause analysis.
  • Apply standard data analysis practices to establish root causes for product and process failures or support improvements.
• Support Site Quality Activities:
  • Support internal quality audit activities.
  • Champion Quality by ensuring adherence to the QMS, supporting corrective and preventive actions, and contributing to quality KPIs.
  • Perform other duties as directed by supervision.
• Support Integer’s Manufacturing Excellence and Market Focused Innovation Strategies through:
  • Strategy alignment via Site Hoshin Plans, Quality Plans, Validation Master Plans, and quality improvement imperatives.
  • Leadership of sustained change, including customer change notifications and continuous improvement activities.
  • Standardization through workplace organization (5S), Manufacturing Standard Work, and robust training programs.
  • Associate engagement via problem-solving methodologies, behavior-based safety programs, and improvement idea systems.
  • Systems and process optimization through built-in-quality principles.

How Success Is Measured

• Active support of Integer’s Environmental, Health & Safety programs.
• Adherence to Integer’s Values: Customer, Integrity, Candor, Inclusion, Collaboration, Innovation.
• Defined goals and objectives with key projects and expected milestones.
• Quality metrics: Customer Direct Complaint Rate, NCR rate, Complaint Cycle Time, CAPA Cycle Time.
• Innovation and ideation through continuous improvement suggestions and implementation support.

Requirements

• Minimum Education: Bachelor’s degree in engineering or related field with 3+ years of relevant experience. Candidates without a degree 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).
  • Proficiency in Microsoft Office.
  • Ability to work independently and collaboratively with cross-functional teams.
• Specialized Skills:
  • Solid technical aptitude with the ability to contribute individually or as part of a team.
  • Strong written and oral communication skills (English required for non-U.S. roles).
  • Ability to maintain composure in a high-energy, constantly changing production environment.
  • Positive, can-do attitude with a commitment to excellence.

Benefits

• Competitive base salary and cash-based incentive program (pay-for-performance philosophy).
• Comprehensive benefits package with immediate eligibility, including:
  • Medical, dental, vision, disability, and life insurance.
  • Adoption benefits and parental leave (after one year).
  • Optional employee-paid programs: supplemental life insurance, critical illness, hospital indemnity, and accident insurance.
• 401(k) plan with company matching contributions (immediate eligibility).
• 80 hours (10 days) of company-designated holidays per year plus an annual allotment of paid time off.

U.S. Applicants: Equal Opportunity Employer. Veterans and individuals with disabilities are encouraged to apply.