Lead Quality Technician

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

• Inspects incoming materials and finished goods to verify conformance to specification and helps develop and implement inspection methods and quality plans.
• Provides supports for QMS processes including:
• CAPA investigations and Production & Process Controls
• Control of Non-Conforming
• Engineering Change Control
• Must be proficient with general Quality Control and electronic test instruments including multimeters, calipers, pressure gauge, etc. Advanced knowledge of blueprint reading, S.O.P's, GMP's and ISO 13485 standards. Efficient with company computer software to include receiving and inventory transactions and part maintenance. Ability to do basic calibrations, and internal auditing.
• Support incoming materials inspection and inspects and tests finished goods to verify conformance to specification and help develop and implement inspection methods and quality plans. Documents all inspection on a nonconforming material report to ensure disposition and trend analysis as required.
• Works independently in an organized manner with good documentation practices.
• Maintains a clean and safe receiving inspection area.
• Documents all test failures to provide detailed reporting for disposition and trend analysis.
• Must have knowledge of use of general Quality measurement and test instruments including calipers, height gauge, etc. Advanced knowledge of blueprint reading.
• Efficient with company computer software to include receiving and inventory transactions and part maintenance.
• Supports document controls as applicable.
• Participate in continuous improvement teams as assigned.
• Interprets engineering drawings, schematic diagrams, formulas and/or quality receiving inspection sheets and/or engineering staff as required to determine quality and reliability standards.
• Records test data, applying statistical quality control procedures when applicable.
• Set up and perform destructive and nondestructive tests on materials, parts, or products to measure performance, or material characteristics.
• Documents all failures on the DHR form, non-conformance form, and equipment database to facilitate analysis and provide troubleshooting of test failures.
• Assists service department with testing of returned service units.
• Works independently in an organized manner, with good documentation practices.
• Assist in the maintenance of test equipment and equipment used in the manufacture of medical products.
• Completes all testing for evaluation as requested by R&D Engineering, Service and Quality.
• Reviews inspection records and test reports (DHR’S) prior to release of finished devices for shipment. Authorized agent of the company to release medical product for shipment.
• Manages priorities of assigned work to deliver results in a timely manner.
• Working knowledge of GMP's, standards, procedures, and regulations with emphasis on: ISO13485:2003, 21CFR 820
• Knowledgeable on the computer programs utilized by Gentherm

MINIMUM QUALIFICATIONS:

• High School Diploma/GED
• 5 years experience
• Able to analyze and trend data to facilitate continuous improvement efforts within production and assure effectiveness of product.

PREFERRED QUALIFICATIONS:

• Medical Device or Pharmaceutics background
• Auditing Background
• Acceptance Activities Regulations / Requirements
• Investigations Regulations / Requirements

Job Type: Full-time

Pay: $20.60 - $24.81 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Overtime

Work setting:

• In-person
• Manufacturing facility

Work Location: In person

Salary : $21 - $25