Industry: Medical Device Manufacturing
Location: Onsite
Compensation:$25/hr
Type: Direct Hire
Job Functions
- Perform Quality Control inspections to verify materials, products, processes, and controlled environments meet specifications, customer requirements, and Quality System requirements.
- Perform accurate QC measurements and ensure inspection and testing results are thoroughly documented.
- Complete inspections according to established priorities and production schedules.
- Review manufacturing records, including sterile processing data, test results, certifications, labeling, and related documentation for compliance with specifications and Quality System requirements.
- Support Warehouse associates to ensure materials are handled and stored according to applicable specifications and Quality System requirements.
- Maintain accurate, organized, and readily retrievable Quality records to support audits and inspections.
- Verify QC inspection files, documentation, and manufacturing associate training records are current and accurate.
- Identify, document, segregate, and quarantine nonconforming materials to prevent unintended use or mix-ups with acceptable product.
- Assist with investigations of products and processes suspected of being nonconforming.
- Coordinate Material Review Board (MRB) activities to ensure timely disposition of nonconforming materials.
- Communicate with appropriate stakeholders regarding nonconforming materials awaiting MRB review and disposition.
- Maintain controlled access to Quality Assurance Hold and Quarantine areas.
- Inspect returned products and ensure appropriate segregation of nonconforming materials.
- Maintain the equipment calibration program to ensure production, inspection, test, and measurement equipment is calibrated by established due dates.
- Verify equipment is properly identified with current calibration status and remove equipment from service when calibration is expired or equipment is out of calibration.
- Verify preventive maintenance (PM) and equipment qualification activities are completed as required.
- Perform environmental monitoring activities, including temperature and humidity monitoring and Controlled Environment Area (CEA) monitoring/testing according to the Quality System.
- Verify manufacturing and warehouse areas are appropriately cleaned, pest control measures are maintained, and required records are completed.
- Maintain clean and organized work areas.
- Assist with maintaining Quality Assurance work instructions in accordance with current regulations and standards.
- High School Diploma or GED required.
- Minimum of three (3) years of Quality Control and inspection experience within a medical device manufacturing environment.
- Experience preparing technical reports, analysis, and documentation using Microsoft Office.
- Demonstrated ability to read and interpret blueprints, technical documentation, procedures, and product specifications.
- Applied knowledge of Quality Control inspection, testing, and measurement instrumentation.
- Hands-on experience with advanced inspection and measurement equipment, including gauges, micrometers, calipers, indicators, comparators, and microscopes.
- Excellent hand-eye coordination and visual acuity, including color vision, close vision, and the ability to identify fine details under magnification.
- Strong attention to detail with the ability to perform precise measurements and maintain accurate Quality records.
- Excellent written and verbal communication skills with the ability to communicate effectively with auditors, suppliers, management, and cross-functional teams.
- Strong understanding of nonconforming material control, inspection documentation, and regulated manufacturing practices.
- Two-year technical degree preferred.
- Training or certification in ISO 13485 and FDA Quality Systems preferred.
- Experience with sterilization, microbiology, and biocompatibility preferred.
- Strong manual dexterity for detailed inspection and measurement activities.
- Medical device manufacturing, warehouse, and controlled environment/cleanroom setting.
- Regularly required to stand, walk, sit, and use hands to operate inspection tools, measurement equipment, and other manufacturing equipment.
- Requires excellent hand-eye coordination and manual dexterity to perform detailed inspection activities.
- Specific vision abilities required include close vision, color vision, and the ability to identify fine details under magnification.
- Must be able to perform repetitive inspection and measurement activities while maintaining accuracy and attention to detail.
Estimated Min Rate: $36400.00
Estimated Max Rate: $52000.00
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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