Quality Technician
2 months ago
Job Title: Quality Technician - Medical Device Manufacturing
Job Overview:
**Responsibilities**:
- Conduct thorough inspections of incoming parts, components, and materials to ensure compliance with specifications and quality standards.
- Perform in-process inspections at various stages of the manufacturing process to identify any deviations from quality requirements.
- Monitor and enforce Acceptable Quality Levels (AQLs) for both incoming materials and finished products.
- Create and maintain detailed inspection reports, documenting any non-conformities and deviations.
- Collaborate with production and engineering teams to address quality issues and implement corrective actions.
- Assist in the development and improvement of quality control processes and procedures.
- Generate ballooning documents and prepare accurate and detailed inspection plans.
- Work closely with cross-functional teams to ensure that all necessary paperwork, including certificates of conformance, inspection records, and compliance documentation, is completed accurately and on time.
- Participate in root cause analysis investigations and support the implementation of corrective and preventive actions.
- Keep up-to-date with industry standards, regulations, and best practices related to medical device manufacturing and quality control.
- Contribute to continuous improvement initiatives aimed at enhancing product quality, reliability, and customer satisfaction.
Qualifications:
- High school diploma or equivalent; technical or vocational education in a relevant field is a plus.
- Proven experience working as a Quality Technician or in a similar role within the medical device manufacturing industry.
- Solid understanding of quality control principles, methodologies, and tools.
- Familiarity with relevant regulations and standards such as ISO 13485, FDA QSR, and GMP.
- Proficiency in performing part inspections using various measurement equipment and techniques.
- Strong knowledge of Acceptable Quality Levels (AQLs) and statistical sampling techniques.
- Experience in creating and interpreting engineering drawings, including ballooning documents.
- Excellent attention to detail and ability to identify deviations and non-conformities.
- Strong analytical and problem-solving skills.
- Effective communication and interpersonal skills to collaborate with cross-functional teams.
- Proficiency in using quality management software and tools.
- Ability to work independently and manage multiple tasks simultaneously.
- Willingness to adapt to changing priorities and work in a fast-paced manufacturing environment.
Pay: $20.00 - $25.00 per hour
Expected hours: 40 - 45 per week
**Benefits**:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
Schedule:
- Day shift
- Monday to Friday
Work setting:
- In-person
**Experience**:
- Manufacturing: 1 year (required)
- Quality: 1 year (required)
Work Location: In person
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