QA Inspector

Job Title

Responsibilities of essential functions include:

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

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and/or Experience:

• High School diploma or equivalent
• Requires great attention to detail and the ability to read drawings and specifications
• Experience using calipers and micrometers

Language Skills: • 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. Reasoning Ability: • 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. Physical Demands: • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • 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. Work Environment: • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • 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.

Competencies: • 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.

Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.