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?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. 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.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
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.
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