IQA Technician I/Incoming Quality Assurance Technician
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Role details
Tech stack
Job description
- Support manufacturing and testing operations in compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) for receiving and inspection.
- Perform job duties in accordance with Global and Technical Standards and Quality System (QS) requirements.
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Complete Tier 1 inspections per inspection plans and drawings to support production schedules. o Use hand tools (calipers, gauges, rulers) and perform visual inspections on inbound materials for medical device assembly. o May operate more advanced measuring instruments as needed.
- Perform visual and dimensional inspections of cable harness assemblies and printed circuit board assemblies.
- Maintain accurate inspection records, documentation, and filing systems to meet GMP and quality compliance.
- Accept or reject supplier lots based on inspection results.
- Document any non-conformances related to specifications, procedures, or standards, including completing required paperwork and system transactions.
- Initiate discrepant material reports and participate in data collection, analysis, and trending.
- Recommend improvements to policies, processes, and procedures.
- Perform moderately complex assignments, applying established methods to recurring situations; escalate more complex issues to senior quality personnel.
- Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory initiatives.
- Ensure adherence to all FDA, ISO, environmental, health, and safety requirements., o IQA Technician o Quality Technician o Incoming Quality Assurance o Quality Assurance o Quality Control o Medical Device o Manufacturing o GMP o GLP o QMS o EMS o Dimensional Inspection o Visual Inspection o Incoming Inspection o Inspection Plans o Engineering Drawings o Calipers o Gauges o Rulers o Measurement Tools o Cable Harness Assemblies o Printed Circuit Board Assemblies o PCB Assemblies o Supplier Quality o Nonconformance o Discrepant Material Reports o Inspection Records o Quality Systems o FDA o ISO o Regulatory Compliance o Manufacturing Quality o Quality Documentation o Data Analysis o Trend Analysis o High School Diploma o GED
Requirements
- Ability to perform accurate visual and dimensional inspections.
- Knowledge of GMP, GLP, and quality system regulations.
- Strong documentation and record keeping skills.
- Ability to analyze inspection data and identify trends.
- Attention to detail and accuracy.
- Ability to follow standards, procedures, and regulatory guidelines.
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Basic problem solving and initiative to complete tasks independently. Required Experience
- 0-2 years performing incoming dimensional inspections.
- Experience with hand measurement tools such as calipers, gauges, and rulers.
- Work experience supporting manufacturing or quality environments preferred.
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Intern will be considered Preferred Experience (Nice to Have)
- Bachelor’s degree or technical diploma (not required but preferred if no prior inspection experience).
- Familiarity with medical device manufacturing or regulated environments.
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Experience reviewing engineering drawings, specifications, and inspection plans (required) Education
- High School Diploma or GED required.
Benefits & conditions
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - These all are subject to applicable eligibility).
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Prepare application
- Draft this with your agent
- Open in Claude
- Open in ChatGPT
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