Quality Engineer I
About The Position
The Quality Engineer I performs general engineering work using standard methods and tools, ensuring that internal and external customer expectations are met or exceeded with guidance from experienced engineers and managers. The role supports quality activities at a high-volume hydrophobic coating plant, including material review board (MRB) support, CAPA management, complaint investigations, audit support, change management, new product introduction (NPI), and continuous improvement. The position supports manufacturing quality and regulatory compliance, test method development and validation, nonconforming material processes, and site quality activities. The engineer applies Integer’s quality management and production system methodologies to investigate opportunities for product and process improvements, collaborates with colleagues, and contributes to quality plans, metrics, sustained change, standardization, associate engagement, and process optimization. The role may also include other duties as directed by the line of supervision.
Requirements
- Ability to perform general engineering work using standard methods and tools; this is an entry-level engineering role.
- Ability to collaborate, exchange information, ask questions, and check for understanding while developing as an engineer.
- Ability to adhere to quality, safety, environmental, security, FDA, company, and other applicable regulatory requirements.
Responsibilities
- Support regulatory and agency inspections, audits, investigations, and inquiries related to product design and manufacturing quality.
- Monitor manufacturing of assigned products for compliance with the Device Master Record (DMR), provide deviation and waiver guidance, and ensure complete and correct Device History Records are maintained.
- Review changes to bills of materials, assembly procedures, drawings, component specifications, FMEAs, and control plans for adequacy and correctness.
- Participate in continuous improvement projects and assist with product transfers.
- Perform technical project work to investigate product and process improvement opportunities using standard quality management and production system methodologies.
- Generate and complete protocols and reports for test method validations.
- Work 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 inspection techniques and procedures to ensure product integrity against design specifications; write, approve, and implement incoming, in-process, and final inspection procedures.
- Ensure nonconforming material dispositions meet applicable procedures and that corrective actions are adequate to prevent recurrence.
- Lead and manage complaint investigations.
- Participate in plant CAPA activities, including analysis of data and trends involving complaints, supplier quality, nonconforming material, training effectiveness, and root-cause analysis.
- Apply standard data analysis practices and observe products and processes to identify root causes of failures or support product and process improvements.
- Support internal quality audit activities, as applicable.
- Adhere to Integer’s values and safety, environmental, security, quality, FDA, company policy, operating procedure, and other regulatory requirements.
- Support adherence to the Quality Management System, corrective and preventive action investigations and implementation, quality KPIs, and the site’s quality improvement objectives.
- Support site strategy through Hoshin plans, quality plans, validation master plans, quality improvement initiatives, and QA/RA weekly and monthly metrics.
- Support customer change notifications and continuous improvement activities.
- Contribute to workplace organization and visual controls (5S), manufacturing standard work, and training and certification programs where applicable.
- Promote standardized problem-solving methods, behavior-based safety programs, and improvement idea and suggestion systems.
- Support optimization of systems and processes through built-in-quality principles.
- Perform other duties as needed and as directed by the line of supervision.
Benefits
- Base salary and a cash-based incentive program.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- Disability insurance.
- Life insurance.
- Adoption benefits.
- Parental leave after one year.
- Optional employee-paid 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.
- Annual allotment of paid time off.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
