2nd Shift Quality Control Inspector III

2nd Shift Quality Control Inspector III

M-F 3:30PM-11:30PM (willing to allow split shift work 11AM-7PM or 12PM-8PM if needed)

$19-$26/hr. depending on experience

OVERVIEW:

The QC Inspector III is responsible for all aspects of the incoming inspection, in-process and final inspection for medical devices, support investigating CAPA and customer complaints, review of DHRs (device history records), internal audits, calibration, and testing for process validation for the Company assuring compliance with all applicable regulations and industry standards. The role requires an individual who can work independently and with a high level of accuracy, as well as a willingness to lead process improvements and mentor junior team members.

• Assist in producing Quality Products on time and within budget.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Follow written procedures for testing and legibly and accurately document all test data.
• Maintaining compliance with appropriate US FDA regulations and ISO 13485 Quality Management System standards by following written procedures.
• Working in a team environment with all quality control inspection personnel.
• Lead and manage the inspection process (incoming, in-process, and final) for medical devices, including developing and maintaining inspection procedures, and ensuring compliance with regulatory and company requirements.
• Work directly with manufacturing and engineering personnel to test and inspect components and materials.
• Review and approve inspection results and related documentation, including NCRs and corrective actions.
• Performing investigations for: NCRs, Preventive and Corrective Actions, Deviations, and Complaints
• Reviewing Device History Records (DHR) and providing test/inspection support to all new process developments. Reviewing lab results and approve product release.
• Provide technical expertise and training to junior QC inspectors and other departments as needed.
• Participate in external audits and inspections, including preparing for and responding to audit findings as needed.
• Continuously identify areas for process improvement and cost savings, and lead implementation of process improvements.
• Maintain calibration activities and schedules.
• Maintain accurate and up-to-date records of inspection results and related documentation.
• The ability to use manual dexterity to measure, using rulers, calipers, micrometers, and other instruments.
• Working in a team environment with all quality control inspection personnel.
• Support the QC Supervisor as needed.

QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• High school or GED equivalent, Associate's degree in a technical field or equivalent experience
• At least 5 years of experience in quality control or a related field, with at least 5 years in medical device manufacturing or a related industry
• Strong knowledge of medical device regulations and standards, including FDA regulations and ISO 13485 and GMP.
• Knowledgeable in applications of caliper use, calibration and verification of tools, basic math skills and blueprints/drawings comprehension, SPC, IQ/OQ/PQ and quality principles.
• Proficiency in using a wide range of measuring tools and equipment.
• Detail-oriented with excellent organizational and communication skills.
• Attention to Detail in a fast-paced environment
• Ability to work independently and as part of a team, and to lead and mentor others.
• Proficient in Microsoft Office applications, including Word and Excel.
• Any certifications are a plus.

PHYSICAL DEMANDS:

• Must be physically able to sit or stand for extended periods of time.
• Must have the ability to walk extended distances as needed.
• Clarity of vision at 20 inches or more; able to view a computer monitor for extended periods of time.

Job Type: Full-time

Pay: $19.00 - $26.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Vision insurance

Work Location: In person

Salary : $19 - $26