Quality Inspector I

About the role

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Responsibilities

• Perform inspection by using a variety of inspection measuring and test equipment to determine acceptance or rejection of material or parts.
• Perform first article, incoming/receiving, and in-process inspections of materials or parts; determine acceptance or rejection after inspection and/or testing of materials, parts, and/or equipment.
• Interpret and work within the guidelines of drawings, specifications, charts, procedures, and other data to determine acceptance or rejection of materials.
• Read and interpret sampling plans as per the American National Standards Institute (ANSI).
• Aid in training new associates according to the Quality System Regulations and company SOPs as applicable.
• Maintain accurate and current inspection and/or testing records such as Material Certifications, Inspection/Test Results and reports, Certificates of Conformance, Rejection reports/tags, as required by applicable procedure and/or specification.
• Assist in reviewing inspection reports, completed Quality forms, logbooks, and associated Quality forms.
• Inspection requirements include training and working in classified clean rooms as necessary to perform in-process inspections.
• Absorb line clearances and quality reviews in manufacturing, labeling, or other assigned areas during manufacturing activities.
• Maintain records of inspection and all testing performed on the appropriate test records.
• Absorb physical moving and labeling of non-conforming material and customer returned material, including rework, scrap, and return to vendor.
• Maintain the QC inspection areas in an orderly fashion conducive to carrying out safe and efficient inspections and procedures.
• May also perform other related duties, responsibilities, and special projects as assigned.

Qualifications

• High School Diploma.
• QA experience in the medical device industry preferred.
• Strong organizational skills, self-directed, strong problem-solving and interpersonal skills.
• Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP preferred.
• Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) preferred.
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Ability to work effectively in a cross-functional environment.
• Ability to integrate quality objectives across multiple functions.
• Attention to detail and strong time management are essential.
• Must be able to work independently with minimal supervision.

Benefits

• Medical
• Dental
• Vision
• Life Insurance
• Short- and Long-Term Disability
• Business Accident Insurance
• Group Legal Insurance
• Savings Plan (401(k))

Pay

The pay range for this role is $19.19 - $25.43 USD hourly. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation.