Quality Control Inspector II
About The Position
Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. 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. The Quality Inspector II will be responsible for performing quality assurance inspections on purchased components, manufactured sub-assemblies and final product. The Quality Inspector will perform all duties in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies. Expectations are to be familiar with and able to measure critical dimensions.
Requirements
- Associate degree in science is preferred.
- 3-7 years of relevant GMP/GLP experience specific to incoming, line clearance, in-process, and finished goods inspections in pharmaceutical or medical device industry.
- QA experience in the medical device industry preferred.
- Must have strong written and verbal communication skills.
- Strong organizational skills, self-directed, strong problem solving and interpersonal skills.
- Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP.
- Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) preferred.
Nice To Haves
- Knowledge of CAPA, Validations, Change Control, preferred.
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 guideline of drawings, specifications, charts, procedures, and other data to determine acceptance or rejection of materials.
- Read and interpret sampling pan as per the American national standard institute (ANSI)
- Assist in the review and disposition of non-conforming material and customer returned material, including rework, scrap, and return to vendor.
- Maintain accurate and current inspection and/or testing records such as nit not limited to Material Certifications, Inspection/Test Results and reports, Certificates of Conformance, Rejection reports/tags, as required by applicable procedure and/or specification.
- Coordinate and inform other departments of inspection and/or testing status in support of production and project goals and initiatives.
- Promote and participate in continuous improvement initiatives.
- Responsible for the maintenance of appropriate conditions of all quarantine locations.
- Maintain the QC inspection areas in an orderly fashion conducive to carrying out safe and efficient inspections and procedures.
- Inspection requirements include training and working in classified clean rooms as necessary to perform in process inspections.
- Maintain records of inspection and all testing performed on the appropriate test records.
- Perform line clearances and quality reviews in manufacturing, labeling, or other assigned areas during manufacturing activities.
- Identify and implement opportunities for continuous improvement, including document revisions in order to maintain accurate SOPs.
- Provide quality support to various departments as needed, e.g. engineering, product development, etc.)
- Assist in training new associates according to the Quality System Regulations and company SOPs as applicable.
- May also perform other related duties, responsibilities, and special projects as assigned.
Benefits
- Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
- Subject to the terms of their respective policies and date of hire, Employees are eligible for the following https://jobs.integralife.com/total-rewards/
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
Number of Employees
1,001-5,000 employees
