Job Title: Quality Technician - Medical Device Manufacturing
Job Overview:
We are seeking a skilled and detail-oriented Quality Technician to join our medical device manufacturing team. The Quality Technician will play a crucial role in ensuring the highest level of quality and compliance with regulatory standards throughout the production process. The successful candidate will be responsible for performing part inspections, conducting in-process inspections, managing Acceptable Quality Levels (AQLs), generating reports, creating ballooning documents, and preparing necessary paperwork.
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.
If you are a meticulous and dedicated individual with a passion for maintaining high-quality standards in medical device manufacturing, we encourage you to apply for the position of Quality Technician. Join our team and contribute to improving patient outcomes through exceptional product quality.
Job Type: Full-time
Pay: $22.00 - $25.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
Schedule:
- Day shift
- Monday to Friday
Work Location: In person
