QA Inspector

Responsibilities

• Receive, unpack, and verify count of products and condition of receipt
• Inspect incoming materials and finished goods to technical drawings or product specifications by performing dimensional measurements, function tests and pattern assessments
• Document inspection results by inputting data into quality database, completing forms and logs, summarizing inspection findings and rejecting non-conforming material
• Laser mark and electro chemical etch, neutralize and clean products
• Process product returns and complaints, including evaluation of quality issues and initiating repairs or reworks as needed
• Ensure the company’s products comply with all FDA regulations, prepare submissions and maintain regulatory databases
• Adhere strictly to all CGMP, FDA 21 CFR820, ISO 13485, EU MDR and company procedures to ensure the quality and integrity of the products and safety of the workplace
• Keep Quality area organized and clean
• Keep stock of Quality materials such as tip protectors, test materials, etc.
• Conduct training on receiving and inspections and orientation for new hires
• Maintain commitment to Quality Goals and Quality Policy
• Complete jobs and tasks as assigned
• Must be able to work in a team environment

Qualifications

• High School diploma or equivalent
• Requires great attention to detail and the ability to read drawings and specifications
• Experience using calipers and micrometers
• Ability to read and comprehend simple instructions, short correspondence, and memos.
• Ability to write simple correspondence.
• Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
• Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions.
• Ability to deal with problems involving a few concrete variables in standardized situations.
• While performing the duties of this job, the employee is regularly required to stand, walk, and use hands to finger, handle or feel objects, tools or controls.
• The employee frequently is required to talk and hear and occasionally to reach with hands and arms and stoop, kneel, crouch, or crawl.
• Must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required by this job include close vision, peripheral vision, depth perception and the ability to adjust focus.
• While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts.
• The noise level in the work environment is usually moderate to loud.
• Attendance/Punctuality - Is consistently at work and on time.
• Dependability - Follows instructions, responds to management direction.
• Quality - Demonstrates accuracy and thoroughness; monitors own work to ensure quality.
• Safety and Security - Observes safety and security procedures; reports potentially unsafe conditions; uses equipment and materials properly.

Schedule

• Monday - Friday, 8hrs/day.
• Scheduled arrival & departure time is flexible and determined upon hire.