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Quality Assurance Inspector I
2 months ago
GLAUKOS - QUALITY ASSURANCE INSPECTOR I - 2ND SHIFT
What is the role?
The Quality Assurance Inspector I is tasked with overseeing all facets of inspection, including receiving, in-process, and final inspections. This role also encompasses providing support for Quality System Regulations (QSR) in various Quality Assurance activities such as calibration, environmental monitoring, product testing, and label control.
Key Responsibilities
Receiving Inspection
- Conduct receiving inspections of components in accordance with established procedures, specifications, and technical drawings.
- Utilize a range of standard metrology instruments, such as optical comparators, height gauges, coordinate measuring machines (CMM), and various other measuring devices.
- Interpret engineering drawings and apply geometric dimensioning and tolerancing principles.
- Review relevant documentation, maintain inspection records adhering to good documentation practices, and authorize component releases.
- Program automated routines for multi-part inspections using the Smartscope system.
- Draft clear and concise inspection procedures for components and machined tubing.
- Handle and process delicate components with precision to avoid damage.
- Perform line clearance for operational activities.
- Inspect and approve labeling.
- Review device history records for lot release, ensuring compliance with documentation practices.
- Conduct inspections on components and assemblies during manufacturing processes.
- Examine device history records for lot release, ensuring all quality documentation complies with internal protocols.
- Perform final inspections on finished products.
- Verify finished goods for correct labeling, packaging, and tamper seals according to established procedures.
- Coordinate final inspection tasks with external vendors.
- Conduct in-house peel testing on sealed packages.
- Manage the sample retention area.
- Collaborate with engineering teams to design high-quality inspection and metrology fixtures.
- Support equipment and process validation activities by inspecting process outputs.
- Conduct periodic compliance audits of manufacturing operations and procedures to ensure cGMP adherence.
- Ensure daily quality records and company practices align with internal procedures and regulations.
- Oversee monthly environmental monitoring of cleanroom facilities.
- Coordinate quarterly dose audits.
- High School Diploma is required.
- 0-2 years of relevant industry experience.
- Experience in the medical device industry and familiarity with QSR is essential.
- Experience in cleanroom environments and performing in-process assembly and manufacturing verification inspections is preferred.
- Strong attention to detail and accuracy is critical.
- Excellent documentation skills are necessary.
- Ability to work collaboratively as part of a team and communicate effectively, both in writing and verbally.
- Organizational skills and the ability to coordinate activities with external vendors are important.
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.
Founded in 1998, Glaukos Corporation is dedicated to developing and commercializing innovative therapies for the treatment of glaucoma and other eye diseases. Our mission is to transform vision care through pioneering dropless therapies that enhance patient outcomes. Innovation drives our efforts as we challenge conventional approaches to treatment with scientifically supported alternatives. Our commitment to groundbreaking technologies is reflected in our mantra, "We'll Go First," emphasizing our readiness to take risks and continuously improve. Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer, ensuring fair consideration for all qualified applicants.
