Quality Control Inspector

Primary Duties and Responsibilities

• Responsible for performing receiving inspection on material / products supplied to Anteris to ensure conformance to requirements and specifications.
• Perform microscope and other aided visual inspections on biological tissue based medical device products to ensure conformance to processing requirements and specifications.
• Perform machine / software-controlled inspections on products to ensure conformance to processing requirements and specifications.
• Perform inspections, as required by procedure, in support of first article inspections and label verifications.
• Perform physical and visual inspections on material, products, and/or packaging being processed for sterilization.
• Make an informed decision, based on training to tasks assigned, on the acceptance of materials, products, and inspected features, requirements, and specifications in all standard work tasks.
• Complete and maintain accurate records of inspection activities, including measurements, observations, results, conclusions, nonconformance issues, and full completion of quality record fields in support of standard work tasks.
• Collaborate with peers in Operations to effectively stay on plan, be mutually organized to goals, and communicate effectively through escalation channels as required.

Skills, Knowledge, Experience & Qualifications

• Physical Requirements: Ability to stand or sit for extended periods of time, often for the majority of the work shift; ability to perform repetitive hand and finger movements requiring high levels of dexterity and precision; ability to lift and move materials up to 25 pounds (or another weight appropriate for your environment); ability to maintain steady hand control for delicate work involving small components or biological materials; ability to work under magnification, including frequent use of microscopes or magnifying equipment for extended periods; ability to visually inspect small components or tissue structures with a high degree of accuracy; ability to maintain sustained focus on detailed tasks in a production or laboratory environment; ability to perform visual and dimensional inspection of small components using microscopes and measurement tools; ability to document inspection results accurately in quality systems or electronic records; ability to maintain accuracy and consistency while performing repetitive tasks that require sustained focus and attention to detail.
• Work Environment: Work is performed in a cleanroom and/or controlled laboratory environment; employees must adhere to strict gowning procedures, which may include wearing gowns, gloves, masks, hair covers, and shoe covers; must be able to work comfortably in a temperature- and humidity-controlled environment; may require handling biological materials, including treated animal tissue, in accordance with established safety and regulatory protocols; must follow cGMP, ISO, and company quality system procedures at all times; ability to work in a highly regulated medical device manufacturing environment with strict documentation and process controls; ability to work independently with minimal supervision while consistently following established procedures, work instructions, and quality standards.
• Required Skills and Knowledge: High School diploma or equivalent; 2+ years’ overall experience in Medical Device (ISO 13485, FDA QSR) manufacturing environment; 1+ year's equivalent work experience directly applicable to Primary Duties and Responsibilities listed above; strong attention to detail and experience in reading, interpreting, and comprehending product requirement documents and specifications; experience in learning and cross-training on widening set of responsibilities in a team-based environment; experience working directly with computers to input data, perform electronic based work tasks, complete training, and manage email communications; effective verbal and written communication; ability to work in a fast-paced environment; effective problem-solving and troubleshooting skills.

Compensation

• Target base salary range: $22 - $28 /hr. Final compensation will be based on experience and alignment with role requirements.