Senior Quality Control Inspector

Yoh,-A-Day-; Saint Paul (MN); Presencial; USD 36.000 - 55.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Prescription, Dental & Vision

401K Retirement Savings Plan

Direct Deposit & weekly epayroll

Descripción de la vacante

Yoh, a Day & Zimmermann company, is seeking a Senior Quality Control Inspector in Saint Paul, MN to perform QC inspections, laboratory testing, and product acceptance for sterile and non-sterile medical devices. You will verify conformance to specifications and regulatory standards while supporting manufacturing, lab, and quality operations.

The role requires an Associate degree or higher in a STEM field and at least 3 years of QC experience in medical devices.

Formación

• Associate degree or higher in a STEM discipline is required.
• 3+ years of quality control experience in medical device manufacturing.
• Ability to interpret blueprints and specifications.
• Experience with MS Office for reporting.
• Strong attention to detail and accuracy.

Responsabilidades

• Perform QC inspections at incoming, in-process, final, and finished product stages.
• Record inspection results with precision and documentation.
• Ensure testing aligns with schedules and priorities.
• Review manufacturing records for compliance with specifications and quality systems.
• Support QA holds, MRB processes, and calibration program.

Conocimientos

Quality control

Inspections

Documentation

Laboratory testing

Calibration

Educación

Associate degree or higher in STEM

Herramientas

Gauges

Micrometers

Calipers

Indicators

Microscopes

Descripción del empleo

Senior Quality Control Inspector (BH-399783-2)

Location Saint Paul, United States Sector Pharmaceuticals Salary $26.00 to $28.00 per hour

Yoh is hiring a Senior Quality Control Technician for our medical device manufacturing client in St. Paul, MN. In this role, you will be responsible for performing quality control inspections, laboratory testing, and product acceptance activities for sterile and non-sterile medical devices. The Senior Quality Control Technician will ensure products meet approved specifications, procedures, customer requirements, and applicable regulatory standards while supporting manufacturing, laboratory, and quality operations.

Industry

Medical Device Manufacturing

Location

St. Paul, MN

Compensation

$28/hr

Type

Direct Hire

Job Functions

• Perform incoming, in-process, final, and finished product QC inspections to verify conformance to specifications, customer requirements, and quality system requirements.
• Perform accurate measurements and document inspection and testing results with a high level of attention to detail.
• Ensure inspections and testing activities are completed in accordance with production schedules and established priorities.
• Review manufacturing records, sterile processing documentation, test results, certifications, labeling, and related paperwork for compliance with specifications and quality system requirements.
• Support Warehouse associates to ensure materials are properly handled and stored according to specifications and quality system requirements.
• Collect, prepare, and submit samples to internal and external laboratories.
• Prepare sterilization documentation and analyze sterilization and biological indicator results.
• Perform UV-Vis, FTIR, and basic wet chemistry testing and analyze results against established specifications.
• Prepare and mix chemical formulations for Production and Manufacturing use.
• Perform environmental monitoring activities, including temperature and humidity monitoring and controlled environment testing.
• Identify, document, segregate, and quarantine nonconforming materials to prevent unintended use.
• Assist with investigations involving products or processes suspected of being nonconforming.
• Coordinate Material Review Board activities and support timely disposition of nonconforming materials.
• Communicate with applicable stakeholders regarding materials awaiting MRB review, action, or disposition.
• Maintain controlled access to QA Hold and Quarantine areas.
• Inspect returned goods and ensure nonconforming materials are appropriately segregated.
• Maintain the equipment calibration program to ensure production, test, and measurement equipment is calibrated by required due dates.
• Verify equipment is appropriately identified with calibration status and remove equipment from service when calibration is expired or out of specification.
• Verify preventive maintenance and equipment qualification activities are completed as required.
• Assist with maintaining Quality Assurance work instructions in accordance with current regulations, standards, and quality system requirements.

Education

• Licensure and/or Experience
• Associate degree or higher in a STEM-related discipline required.
• 3+ years of experience in quality control and inspection within a medical device manufacturing environment.
• Experience preparing technical reports, analyses, and documentation using Microsoft Office.
• Ability to interpret blueprints, technical documentation, specifications, and procedures.
• Working knowledge of analytical chemistry.
• Applied knowledge of quality control, inspection methodologies, and test and measurement instrumentation.
• Experience using measurement and inspection instruments including gauges, micrometers, calipers, indicators, comparators, and microscopes.
• Strong attention to detail with the ability to produce precise measurements, documentation, and quality records.
• Excellent written and verbal communication skills with the ability to communicate effectively with auditors, suppliers, management, and cross-functional teams.
• Excellent hand-eye coordination and visual acuity, including color vision, close vision, and the ability to identify fine details under magnification.

Preferred Qualifications

• Two-year technical degree.
• Training or certification related to ISO 13485 and FDA quality systems.
• Experience with sterilization, microbiology, and chemistry.
• Knowledge of Good Laboratory Practices.
• Strong manual dexterity.

Physical Job Requirements

• Regularly required to stand, walk, sit, and use hands to manipulate, handle, or operate objects, tools, controls, and office equipment.
• Frequently required to communicate verbally and hear.
• Occasionally required to lift and/or move up to 10 pounds.
• Specific vision requirements include close vision, color vision, and the ability to adjust focus.
• Reasonable accommodations may be provided to enable individuals with disabilities to perform the essential functions of the position.

Estimated Min Rate

$36400.00

Estimated Max Rate

$55000.00

What's In It for You?

Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.