Quality Assurance Inspector I - temp -Req#2496 (First Shift - Oberlin)
Job Description
Shift: First Shift - temporary for a couple of months - must be able to commit to duration of project.
Salary Range: $19.00 – $20.00 per hour
Position Summary
The Quality Assurance Inspector I is responsible for inspecting in-process and finished goods within manufacturing areas to ensure compliance with ISO 13485:2016, FDA regulations, and customer specifications. This role supports quality assurance processes by performing inspections, maintaining documentation, and ensuring adherence to regulatory and safety standards.
Essential Duties and Responsibilities
- Conduct in-process and final inspections and testing as required
- Perform visual inspections of finished products
- Participate in internal assessments and audits
- Maintain accurate inspection and test records
- Identify and properly label non-conforming materials
- Communicate product/material acceptability to production personnel
- Assist with technical problem-solving and special projects
- Maintain lot traceability, log sheets, and housekeeping standards
- Follow safety policies and regulations to ensure safe work practices
- Ensure lab cleanliness and safety standards are upheld
- Perform thorough inspections during and after production to ensure quality and compliance
- Verify product labeling for accuracy and regulatory compliance
- Clear and prepare production lines for subsequent runs
- Review and validate Device History Records (DHRs) for completeness and compliance
- Perform other duties as assigned
Qualifications and Experience
Required:
- High school diploma or equivalent
- Completion of 8 hours of Quality Training (PTC)
- Strong attention to detail
- Basic arithmetic and problem-solving skills
- Understanding of raw materials, production processes, and quality control
- Familiarity with administrative procedures and computer systems
- Effective written and verbal communication skills
- Ability to interpret technical drawings, artwork, and procedures
- Commitment to safety and quality standards
- Ability to follow site protocols, policies, and procedures
- Strong organizational and time-management skills
- Ability to work independently and remain flexible and motivated
- Willingness to learn technical concepts through documentation and training
Preferred:
- Experience in a GMP-regulated facility
Preferred Knowledge of Regulatory Standards
- cGMP
- ISO 13485
- 21 CFR Part 820
- CMDR SOR/98-282
Meet Your Recruiter
Hillary Kingsley
Senior Account Manager
Hillary began working with Marquee Staffing in 2011 as a Receptionist. She quickly learned the industry, and developed a passion for recruiting with a focus on the fields of Production, Human Resources, Accounting, Engineering, and Customer Service. Her natural ability to develop relationships made her invaluable among her candidates as well as her clients. Currently operating as our Sr Account Manager, Hillary thrives on providing exceptional customer service while delivering on her client’s needs. Her ability to produce a high caliber of talent combined with her vivacious personality have added immeasurable value to our organization.
Outside of work, Hillary makes sure to make every moment count, and never takes anything for granted. She enjoys going on scenic drives with her family and watching her boys grow up.