Description
Essential Duties and Responsibilities, but are not limited to the following:
- Perform incoming inspection of raw material.
- Assist on the first article inspection of the part to ensure conformance prior start running the job.
- Perform final inspections on productions parts per applicable procedures. Ensure that inspections are performed with the proper gages or inspection equipment and document Generate reports from inspection equipment or company systems if applicable.
- Perform line clearance verification in the production floor to ensure compliance with company procedures.
- Review documents, inspect and sign off for service provided by external suppliers.
- Complete Certificate of Compliance for products in accordance to company procedures before releasing production for shipment.
- During shipment, inspect parts packaging, identification and documentation to ensure compliance with applicable procedures and/or customer requirements.
- Responsible of generating Non Conformance Report (NCR) of products and material and notify the supervisor of any discrepancy found.
- Ensure that all non-conforming material is placed in MRB cabinet, is properly labeled and segregated to avoid product mixups.
- Communicate via email non-conformance documentation status and ensure appropriate disposition approvals are completed prior release of parts.
- Perform inspections in vision system using determined programs.
- Perform set up of the equipment per applicable procedures.
- Document inspections following company Good Documentation Procedures.
- Participate in gauge R&R studies for measurement system analysis.
- Ensure that equipment utilized to inspect and release product is in good working condition and within its calibration period.
- Maintain proper use and care for measurement equipment.
- Notify Supervisor of documentation incongruencies or areas to improve.
- Complete operational paperwork and validations as required.
- Participate and support continuous improvement objectives of the department.
- Provide training to employees:
- On quality issues.
- To inspect run specific jobs.
- On inspection criteria and techniques.
- Perform as a quality resource for other employees.
Requirements
Education and/or Experience:
- High School Diploma,
- Experience in a manufacturing environment, preferred
- Experience in quality, blue prints reading, use of measurement tools such as micromenter and caliper, preferred.
Other Qualifications:
- Familiarity with ISO-9001, ISO 13485 or other quality standards
- Basic understanding of mathematics
- Basic to Intermediate knowledge of Word, Excel, Power Point, and data entry skills
- Strong attention to detail and numerical accuracy and ability to detect errors on documents
- Ability to perform data entry of information fast and error free
- Ability to work effectively with all levels of the organization and influence teams to exceed expectations
- Written and verbal communication skills
- Interest in learning and continued professional growth
- Must be flexible and willing to learn all duties of the department
- Ability to work in a fast-paced production driven environment
- Ability to perform in a regulated work environment, cGMP, ISO and other applicable Standards
- Able to read blue prints and verify dimensional data using various inspection equipment such as calipers, go/no gauges, tape measures, etc. CMM experience is a plus.
- Familiar with Statistical Process Control (SPC), able to review results and initiate actions.
- Knowledge and skill of measuring and inspection equipment
- Familiarity with Geometric Dimensioning and Tolerancing
- Ability to interpret drawings
Summary
Perform documented inspections to incoming products, received services and production lots in accordance with company procedures, applicable standards, or customer specifications. Adhere to company quality manual, procedures, and work instructions to ensure all processing and fabrication operations follow requirements. Train employees to inspect components per standard operating procedures. This function execute under supervision. Employee must comply with company quality standards and guidelines.