2+ years of experience in a regulated environment preferred., Knowledge of ISO standards, particularly ISO 9001 and ISO 13485., Strong problem-solving skills and efficient time management abilities., Associate/Technical Degree, Bachelor’s degree, or equivalent work experience. .
Key responsibilities:
Inspect incoming and in-process materials to ensure product specifications are met.
Conduct final visual inspections of finished goods for labeling and cosmetic issues.
Support investigations of non-conforming materials and coordinate containment efforts.
Assist in the creation or revision of quality inspection plans and procedures.
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Vantage MedTech provides comprehensive design and manufacturing services, supporting the advancement of medical technologies from concept through to product realization. Partnering with the world’s most innovative MedTech start-ups and large medical device companies, we offer feasibility support, product development and prototyping, new product development, clinical and commercial manufacturing, and after-market services to support every phase of the product life cycle.
Our clients can leverage our proprietary Advantage Platforms™, accelerating product development timelines. Our manufacturing approach is structured to serve the changing needs of our clients, supporting small-quantity clinical or First-in-Human builds and can scale to accommodate full launch quantities. Vantage MedTech has facilities in Moonachie, New Jersey and Lenexa, Kansas.
Visit www.vantagemedtech.com for more information.
Job Title: Quality Assurance Technician Location: Lenexa, KS Department: Quality Reports to: Director of Quality and Regulatory
Vantage MedTech provides comprehensive design and manufacturing services, supporting the advancement of medical technologies from concept through to product realization. We develop and manufacture new products for the treatment of heart failure, cancer, stroke, Gene Therapy, COPD, TBI, Atrial Fibrillation, Blood Clots, Brain Surgery, and many more! We are searching for top-tier talent to apply their gifts to making life better for hundreds of thousands of patients worldwide. If this is something you aspire to, we would like to talk with you!
Vantage MedTech has an exciting opportunity available for a Quality Assurance Technician to join our team. The Quality Assurance Technician plays a pivotal role in the inspection of materials and assurance that specifications are consistently met through the production process. The ideal candidate will work to support our overall quality control strategy, can read and understand engineering specifications, and possesses strong problem solving and time management skills. Candidates should have knowledge of ISO standards and experience working in a Quality Controlled environment. Experience with the inspection of electrical components is highly desirable!
**This is not a remote opportunity. This position is based in Lenexa, KS. Local candidates only. We do not offer relocation assistance.
Key Responsibilities:
Inspect incoming materials to confirm that product meets specifications.
Inspect in-process materials to verify product conformity to specifications and review documentation for completion and passing test results.
Provide a final visual inspection of finished goods to verify correct labeling and that the product is free of cosmetic issues (defects, cleanliness).
Identify and support investigations of non-conforming materials.
Support the new product and process verifications and inspection requirements.
Coordinate containment efforts to ensure that known quality risks are under control.
Support overall quality control strategy by assisting in the creation or revision of quality inspection plans, inspection requirements, NCPR procedures, and general QMS procedures.
Understand traceability requirements including product, material, calibration, and record maintenance.
Read and comprehend engineering specifications and dimensioning (Geometric Dimensioning and Tolerancing).
Use of testing and measuring equipment: Calipers, Smart Scopes, Micrometers, and surface plate.
Other duties as assigned.
Education and Experience:
2+ years’ experience working in a regulated environment preferred.
Knowledge of ISO standards including ISO 9001 and ISO 13485 preferred.
Strong problem-solving skills and efficient management of time and resources.
High level of accuracy and attention to detail.
Ability to take direction and work productively with colleagues at all levels.
Basic MS office proficiency (Word, Excel, Outlook).
Associate/Technical Degree, Bachelor’s degree, or equivalent work experience.
Experience with the inspection of electrical components and assemblies preferred.
Top Benefits/Perks: As a team member at Vantage MedTech, you’ll enjoy:
Comprehensive benefits package, including health, vision, and dental insurance.
Generous Paid Time Off.
Company retirement plan with matching.
Vantage MedTech values a diverse team and is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. All applicants must be authorized for full-time employment in the United States. For more information, visit www.vantagemedtech.com
No third-party candidates please.
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English
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