Quality Engineer I

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do.

Values

• Customer – We focus on our customers’ success
• Innovation – We create better solutions
• Collaboration – We create success together
• Inclusion – We always interact with others respectfully
• Candor – We are open and honest with one another
• Integrity – We do the right things and do things right

About the Role

Support all Quality activities of a high-volume hydrophobic coating plant, including:

• MRB support
• CAPA management
• Complaint investigation
• Audit support
• Change management
• NPI activities
• Continuous improvement

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.

Responsibilities

Manufacturing Support

• 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, ensuring compliance with DMR while providing deviation/waiver guidance and maintaining complete and correct Device History Records.
• Review the adequacy and correctness of 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.
• Perform work on technical projects following Integer’s standard quality management and production system methodologies to investigate opportunities for product and process improvements.
• Collaborate with others, ask questions, and regularly check for understanding to support your development as an engineer.

Create Test Methods

• Support 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.
• Recommend process monitoring devices where applicable.
• Develop various inspection techniques and procedures to ensure product integrity to design specifications.
• Write, approve, and implement Incoming, In-Process, and Final Inspection procedures.

Support Non-Conforming Material Process

• Ensure that the disposition of non-conforming materials meets 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 cause analysis.
• Apply standard data analysis practices and observe products and processes to establish root cause for product and process failures or to support the justification for improvements.

Support Site Quality Activities

• Support internal quality audit activities, as applicable.
• Embed Quality – “I own Quality” by assuring adherence to our Quality Management System (QMS), supporting corrective and preventive actions investigation and implementation, and contributing to the successful attainment of our quality KPIs.

Additional Responsibilities

• Support Integer’s Manufacturing Excellence and Market Focused Innovation Strategies through Site Hoshin Plans, Quality Plans, Validation Master Plans, and regular updates to QA/RA metrics.
• Lead sustained change ensuring customer change notifications are initiated and completed, as necessary, and support continuous improvement activities.
• Promote standardization through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs.
• Encourage associate engagement through standardized problem-solving methodologies, behavior-based safety programs, and improvement idea and suggestion systems.
• Optimize systems & processes through adoption of principles of built-in-quality.

Pay

Salary Range: $64,350 - $93,170

Benefits

• Comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.
• Parental leave available after one year.
• Optional employee-paid programs including supplemental life insurance, critical illness, hospital indemnity, and accident insurance.
• Immediate eligibility 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.