Quality Engineer II

Viant; Santo Sé; Presencial; USD 107.000; Tempo integral

Resumo da oferta

An established industry player is seeking a Quality Engineer II to ensure compliance with quality systems in medical device manufacturing. This role involves supporting regulatory inspections, monitoring manufacturing processes, and developing inspection techniques to guarantee product integrity. The ideal candidate will have a strong background in regulatory standards and statistical analysis, along with the ability to lead investigations and implement corrective actions. Join a dynamic team where your expertise will contribute to the success of innovative healthcare solutions.

Qualificações

• 5+ years of engineering experience in medical device or healthcare industry.
• Experience with regulatory standards and statistical analysis.

Responsabilidades

• Support regulatory inspections and ensure compliance with quality systems.
• Develop inspection techniques and conduct capability studies.

Conhecimentos

Regulatory standards (FDA QSR, ISO 13485, ISO 14971)

Statistical analysis

Validation techniques

Interpreting engineering drawings

FMEAs and control plans

Test method validation

CAPA in manufacturing

Inspection procedures

Formação académica

Bachelor’s degree in Industrial Engineering

Descrição da oferta de emprego

Position: Quality Engineer II

Location: 5079 33rd St SE, Grand Rapids, MI 49512, USA

Duties

Responsible for providing quality engineering support for operations to ensure compliance with Quality Systems requirements in medical device manufacturing. Responsibilities include:

1. Supporting regulatory inspections, audits, investigations, and inquiries related to product design and manufacturing quality.
2. Monitoring manufacturing processes and ensuring compliance with Device Master Records (DMR), providing deviation/waiver guidance, and maintaining complete Device History Records.
3. Reviewing Bill of Materials (BOMs), assembly procedures, drawings, component specifications, FMEAs, and control plans for accuracy.
4. Maintaining risk analysis documentation.
5. Completing validation protocols and reports for test methods.
6. Collaborating with manufacturing engineers on process reviews, validations, and capability studies.
7. Developing inspection techniques to ensure product integrity.
8. Ensuring non-conforming materials are dispositioned per regulatory standards and implementing corrective actions.
9. Leading customer complaint investigations and analysis to resolve quality issues.
10. Executing CAPA activities by analyzing data trends and root causes.
11. Performing capability studies and applying statistical quality control tools.
12. Preparing quality plans for new product introductions.
13. Developing documentation for product launches, including validation plans and inspection procedures.
14. Conducting machine and process capability studies, and recommending process improvements.
15. Assessing manufacturing compliance with regulations and recommending enhancements.
16. Training quality assurance inspectors and manufacturing personnel on product specifications and procedures.

Minimum Requirements

Bachelor’s degree or equivalent in Industrial Engineering or related field, with at least 5 years of progressive engineering experience in the medical device, healthcare, or pharmaceutical industry. Additionally, must have 12 months of experience in:

• Regulatory standards including FDA QSR, ISO 13485, ISO 14971
• Statistical analysis and validation techniques
• Interpreting engineering drawings and specifications, working with FMEAs and control plans
• Leading test method validation and documentation
• Conducting CAPA in manufacturing using problem-solving tools
• Developing and implementing inspection procedures

Employer will accept experience gained concurrently. Salary: $106,683/year. Full-time position based in Grand Rapids, MI. Apply online at viantmedical.com/careers/us-jobs/.

This notice relates to a permanent labor certification application. Documentary evidence may be submitted to the U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue NW, Room N-5311, Washington, DC 20210.